Trial Outcomes & Findings for Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis (NCT NCT01029353)
NCT ID: NCT01029353
Last Updated: 2024-07-18
Results Overview
Death or NDI at 18-22 months corrected age
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
529 participants
Primary outcome timeframe
at 18-22 months corrected age
Results posted on
2024-07-18
Participant Flow
Participant milestones
| Measure |
Randomized Trial: Initial Laparotomy
Under general anesthesia in the neonatal intensive care unit (NICU) or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Initial Laparotomy
Under general anesthesia in the neonatal intensive care unit (NICU) or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
148
|
162
|
100
|
119
|
|
Overall Study
Included in ITT Analysis
|
146
|
162
|
100
|
119
|
|
Overall Study
Reached Network Status
|
146
|
162
|
100
|
119
|
|
Overall Study
COMPLETED
|
141
|
154
|
93
|
115
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
7
|
4
|
Reasons for withdrawal
| Measure |
Randomized Trial: Initial Laparotomy
Under general anesthesia in the neonatal intensive care unit (NICU) or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Initial Laparotomy
Under general anesthesia in the neonatal intensive care unit (NICU) or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
5
|
4
|
|
Overall Study
Consent Withdrawn
|
2
|
0
|
0
|
0
|
|
Overall Study
Primary Outcome Indeterminate
|
1
|
3
|
2
|
0
|
Baseline Characteristics
Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis
Baseline characteristics by cohort
| Measure |
Randomized Trial: Initial Laparotomy
n=146 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=162 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Initial Laparotomy
n=100 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
n=119 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Total
n=527 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
11.6 days
STANDARD_DEVIATION 10 • n=99 Participants
|
12.1 days
STANDARD_DEVIATION 9.9 • n=107 Participants
|
79.9 days
STANDARD_DEVIATION 125.4 • n=206 Participants
|
49.9 days
STANDARD_DEVIATION 111.7 • n=157 Participants
|
33.3 days
STANDARD_DEVIATION 81.0 • n=390 Participants
|
|
Sex/Gender, Customized
Female
|
66 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
53 Participants
n=157 Participants
|
230 Participants
n=390 Participants
|
|
Sex/Gender, Customized
Male
|
80 Participants
n=99 Participants
|
98 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
66 Participants
n=157 Participants
|
296 Participants
n=390 Participants
|
|
Sex/Gender, Customized
Missing
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Black
|
62 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
42 Participants
n=157 Participants
|
202 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Missing
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
12 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
6 Participants
n=157 Participants
|
29 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
White
|
73 Participants
n=99 Participants
|
82 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
70 Participants
n=157 Participants
|
284 Participants
n=390 Participants
|
|
Maternal hispanic ethnicity
Missing
|
1 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
9 Participants
n=157 Participants
|
22 Participants
n=390 Participants
|
|
Maternal hispanic ethnicity
No
|
107 Participants
n=99 Participants
|
120 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
95 Participants
n=157 Participants
|
397 Participants
n=390 Participants
|
|
Maternal hispanic ethnicity
Yes
|
38 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
15 Participants
n=157 Participants
|
108 Participants
n=390 Participants
|
|
Infant gestational age
|
25 weeks
STANDARD_DEVIATION 1.7 • n=99 Participants
|
24.9 weeks
STANDARD_DEVIATION 1.7 • n=107 Participants
|
24.6 weeks
STANDARD_DEVIATION 1.1 • n=206 Participants
|
24.5 weeks
STANDARD_DEVIATION 1.2 • n=157 Participants
|
25 weeks
STANDARD_DEVIATION 1.7 • n=390 Participants
|
|
Infant birth weight
|
721.2 gram
STANDARD_DEVIATION 138.4 • n=99 Participants
|
711.4 gram
STANDARD_DEVIATION 135.9 • n=107 Participants
|
719.8 gram
STANDARD_DEVIATION 150.5 • n=206 Participants
|
675.6 gram
STANDARD_DEVIATION 161.7 • n=157 Participants
|
707.6 gram
STANDARD_DEVIATION 146.2 • n=390 Participants
|
|
Infant was small for gestational age
Missing
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
|
Infant was small for gestational age
No
|
131 Participants
n=99 Participants
|
145 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
98 Participants
n=157 Participants
|
458 Participants
n=390 Participants
|
|
Infant was small for gestational age
Yes
|
15 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
21 Participants
n=157 Participants
|
68 Participants
n=390 Participants
|
|
Inborn status
In born
|
82 Participants
n=99 Participants
|
90 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
75 Participants
n=157 Participants
|
312 Participants
n=390 Participants
|
|
Inborn status
Out born
|
64 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
44 Participants
n=157 Participants
|
215 Participants
n=390 Participants
|
|
Infant Apgar score at 1 minute
|
3 units on a scale
n=99 Participants
|
3 units on a scale
n=107 Participants
|
4 units on a scale
n=206 Participants
|
4 units on a scale
n=157 Participants
|
3 units on a scale
n=390 Participants
|
|
Infant Apgar score at 5 minute
|
6 units on a scale
n=99 Participants
|
6 units on a scale
n=107 Participants
|
7 units on a scale
n=206 Participants
|
7 units on a scale
n=157 Participants
|
7 units on a scale
n=390 Participants
|
|
Infant had patent ductus arteriosus (PDA) prior to enrollment
Missing
|
10 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=157 Participants
|
31 Participants
n=390 Participants
|
|
Infant had patent ductus arteriosus (PDA) prior to enrollment
No
|
77 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
56 Participants
n=157 Participants
|
270 Participants
n=390 Participants
|
|
Infant had patent ductus arteriosus (PDA) prior to enrollment
Yes
|
59 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
59 Participants
n=157 Participants
|
226 Participants
n=390 Participants
|
|
Infant received postnatal steroids
No
|
119 Participants
n=99 Participants
|
115 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
83 Participants
n=157 Participants
|
384 Participants
n=390 Participants
|
|
Infant received postnatal steroids
Yes
|
27 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
36 Participants
n=157 Participants
|
143 Participants
n=390 Participants
|
|
Infant received indomethacin before or on Randomization
Missing
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
7 Participants
n=157 Participants
|
19 Participants
n=390 Participants
|
|
Infant received indomethacin before or on Randomization
No
|
69 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
38 Participants
n=157 Participants
|
232 Participants
n=390 Participants
|
|
Infant received indomethacin before or on Randomization
Yes
|
74 Participants
n=99 Participants
|
82 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
74 Participants
n=157 Participants
|
276 Participants
n=390 Participants
|
|
Infant received enteral feedings before or on enrollment
Missing
|
33 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
25 Participants
n=157 Participants
|
112 Participants
n=390 Participants
|
|
Infant received enteral feedings before or on enrollment
No
|
23 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
11 Participants
n=157 Participants
|
68 Participants
n=390 Participants
|
|
Infant received enteral feedings before or on enrollment
Yes
|
90 Participants
n=99 Participants
|
95 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
83 Participants
n=157 Participants
|
347 Participants
n=390 Participants
|
|
Infant had early onset sepsis before or on enrollment
Missing
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
8 Participants
n=390 Participants
|
|
Infant had early onset sepsis before or on enrollment
No
|
143 Participants
n=99 Participants
|
151 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
117 Participants
n=157 Participants
|
509 Participants
n=390 Participants
|
|
Infant had early onset sepsis before or on enrollment
Yes
|
1 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
10 Participants
n=390 Participants
|
|
Infant had late onset sepsis before or on enrollment
Missing
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
3 Participants
n=390 Participants
|
|
Infant had late onset sepsis before or on enrollment
No
|
109 Participants
n=99 Participants
|
113 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
76 Participants
n=157 Participants
|
370 Participants
n=390 Participants
|
|
Infant had late onset sepsis before or on enrollment
Yes
|
37 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
43 Participants
n=157 Participants
|
154 Participants
n=390 Participants
|
|
Infant had severe intraventricular hemorrhage (IVH) (grade 3 or 4)
Missing
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=157 Participants
|
16 Participants
n=390 Participants
|
|
Infant had severe intraventricular hemorrhage (IVH) (grade 3 or 4)
No
|
123 Participants
n=99 Participants
|
134 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
88 Participants
n=157 Participants
|
431 Participants
n=390 Participants
|
|
Infant had severe intraventricular hemorrhage (IVH) (grade 3 or 4)
Yes
|
17 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
27 Participants
n=157 Participants
|
80 Participants
n=390 Participants
|
|
Infant on vasopressors at Enrollment
No
|
105 Participants
n=99 Participants
|
103 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
71 Participants
n=157 Participants
|
334 Participants
n=390 Participants
|
|
Infant on vasopressors at Enrollment
Yes
|
41 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
47 Participants
n=157 Participants
|
192 Participants
n=390 Participants
|
|
Infant on vasopressors at Enrollment
Missing
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
|
Infant received HFOV or HFJV at randomization
No
|
114 Participants
n=99 Participants
|
114 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
66 Participants
n=157 Participants
|
345 Participants
n=390 Participants
|
|
Infant received HFOV or HFJV at randomization
Yes
|
32 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
53 Participants
n=157 Participants
|
182 Participants
n=390 Participants
|
|
Infant pH closest to enrollment
|
7.2 pH
STANDARD_DEVIATION 0.1 • n=99 Participants
|
7.2 pH
STANDARD_DEVIATION 0.1 • n=107 Participants
|
7.2 pH
STANDARD_DEVIATION 0.1 • n=206 Participants
|
7.2 pH
STANDARD_DEVIATION 0.2 • n=157 Participants
|
7.2 pH
STANDARD_DEVIATION 0.1 • n=390 Participants
|
|
Infant fraction of inspired oxygen (FiO2) closest to enrollment
|
44.8 Percent
STANDARD_DEVIATION 26.3 • n=99 Participants
|
45.9 Percent
STANDARD_DEVIATION 24.1 • n=107 Participants
|
57.8 Percent
STANDARD_DEVIATION 29.7 • n=206 Participants
|
53.5 Percent
STANDARD_DEVIATION 30.0 • n=157 Participants
|
49.6 Percent
STANDARD_DEVIATION 27.6 • n=390 Participants
|
|
Infant mean blood pressure
|
37.1 mmHG
STANDARD_DEVIATION 10.3 • n=99 Participants
|
37.0 mmHG
STANDARD_DEVIATION 11.5 • n=107 Participants
|
39.0 mmHG
STANDARD_DEVIATION 11.3 • n=206 Participants
|
36.1 mmHG
STANDARD_DEVIATION 11.7 • n=157 Participants
|
37.2 mmHG
STANDARD_DEVIATION 11.2 • n=390 Participants
|
|
Infant lowest platelet count
|
155.7 1000 platelets per microliter
STANDARD_DEVIATION 96 • n=99 Participants
|
150.4 1000 platelets per microliter
STANDARD_DEVIATION 80.9 • n=107 Participants
|
156.2 1000 platelets per microliter
STANDARD_DEVIATION 91.4 • n=206 Participants
|
131.5 1000 platelets per microliter
STANDARD_DEVIATION 79.6 • n=157 Participants
|
148.7 1000 platelets per microliter
STANDARD_DEVIATION 87.3 • n=390 Participants
|
|
Infant baseline risk of death or neurodevelopmental impairment (NDI)
|
63.4 Percent probability
STANDARD_DEVIATION 27 • n=99 Participants
|
70.7 Percent probability
STANDARD_DEVIATION 23.7 • n=107 Participants
|
88.1 Percent probability
STANDARD_DEVIATION 20.7 • n=206 Participants
|
85.8 Percent probability
STANDARD_DEVIATION 23.1 • n=157 Participants
|
70.3 Percent probability
STANDARD_DEVIATION 25.0 • n=390 Participants
|
|
Infant preoperative diagnosis (NEC or IP)
IP
|
104 Participants
n=99 Participants
|
109 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
72 Participants
n=157 Participants
|
310 Participants
n=390 Participants
|
|
Infant preoperative diagnosis (NEC or IP)
NEC
|
42 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
47 Participants
n=157 Participants
|
217 Participants
n=390 Participants
|
|
Maternal Age, Continuous
|
27.6 years
STANDARD_DEVIATION 6.7 • n=99 Participants
|
27.3 years
STANDARD_DEVIATION 6.3 • n=107 Participants
|
26.7 years
STANDARD_DEVIATION 6.3 • n=206 Participants
|
26.8 years
STANDARD_DEVIATION 6.2 • n=157 Participants
|
27.2 years
STANDARD_DEVIATION 6.4 • n=390 Participants
|
|
Married, Customized
Missing
|
1 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=157 Participants
|
15 Participants
n=390 Participants
|
|
Married, Customized
No
|
81 Participants
n=99 Participants
|
95 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
62 Participants
n=157 Participants
|
288 Participants
n=390 Participants
|
|
Married, Customized
Yes
|
64 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
53 Participants
n=157 Participants
|
224 Participants
n=390 Participants
|
|
Maternal Education, Customized
College graduate
|
18 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
25 Participants
n=157 Participants
|
83 Participants
n=390 Participants
|
|
Maternal Education, Customized
High school graduate
|
42 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
25 Participants
n=157 Participants
|
124 Participants
n=390 Participants
|
|
Maternal Education, Customized
Less than high school
|
21 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
12 Participants
n=157 Participants
|
83 Participants
n=390 Participants
|
|
Maternal Education, Customized
Missing
|
42 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
38 Participants
n=157 Participants
|
156 Participants
n=390 Participants
|
|
Maternal Education, Customized
Some college
|
23 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
19 Participants
n=157 Participants
|
81 Participants
n=390 Participants
|
|
Mother had private insurance
Missing
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
4 Participants
n=390 Participants
|
|
Mother had private insurance
No
|
98 Participants
n=99 Participants
|
113 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
65 Participants
n=157 Participants
|
347 Participants
n=390 Participants
|
|
Mother had private insurance
Yes
|
48 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
53 Participants
n=157 Participants
|
176 Participants
n=390 Participants
|
|
Mother received prenatal care
Missing
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
5 Participants
n=157 Participants
|
15 Participants
n=390 Participants
|
|
Mother received prenatal care
No
|
3 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=157 Participants
|
20 Participants
n=390 Participants
|
|
Mother received prenatal care
Yes
|
142 Participants
n=99 Participants
|
149 Participants
n=107 Participants
|
92 Participants
n=206 Participants
|
109 Participants
n=157 Participants
|
492 Participants
n=390 Participants
|
|
Mother received antibiotics
Missing
|
28 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
18 Participants
n=157 Participants
|
98 Participants
n=390 Participants
|
|
Mother received antibiotics
No
|
39 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
19 Participants
n=157 Participants
|
119 Participants
n=390 Participants
|
|
Mother received antibiotics
Yes
|
79 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
82 Participants
n=157 Participants
|
310 Participants
n=390 Participants
|
|
Rupture of membranes > 18 hours
Missing
|
22 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
6 Participants
n=157 Participants
|
64 Participants
n=390 Participants
|
|
Rupture of membranes > 18 hours
No
|
101 Participants
n=99 Participants
|
108 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
97 Participants
n=157 Participants
|
375 Participants
n=390 Participants
|
|
Rupture of membranes > 18 hours
Yes
|
23 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
16 Participants
n=157 Participants
|
88 Participants
n=390 Participants
|
|
Maternal hypertension
Missing
|
26 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
13 Participants
n=157 Participants
|
80 Participants
n=390 Participants
|
|
Maternal hypertension
No
|
85 Participants
n=99 Participants
|
98 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
84 Participants
n=157 Participants
|
332 Participants
n=390 Participants
|
|
Maternal hypertension
Yes
|
35 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
22 Participants
n=157 Participants
|
115 Participants
n=390 Participants
|
|
Mother received antenatal magnesium
Missing
|
52 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
66 Participants
n=157 Participants
|
245 Participants
n=390 Participants
|
|
Mother received antenatal magnesium
No
|
17 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
7 Participants
n=157 Participants
|
51 Participants
n=390 Participants
|
|
Mother received antenatal magnesium
Yes
|
77 Participants
n=99 Participants
|
73 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
46 Participants
n=157 Participants
|
231 Participants
n=390 Participants
|
|
Mother received steroids
Missing
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
|
Mother received steroids
No
|
22 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
18 Participants
n=157 Participants
|
82 Participants
n=390 Participants
|
|
Mother received steroids
Yes
|
124 Participants
n=99 Participants
|
130 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
101 Participants
n=157 Participants
|
444 Participants
n=390 Participants
|
PRIMARY outcome
Timeframe: at 18-22 months corrected agePopulation: Analysis of randomized trial data included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. Analysis of preference cohort data included all eligible participants who were consented, enrolled, did not withdraw consent, and who provided outcome data.
Death or NDI at 18-22 months corrected age
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=141 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=154 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
n=93 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
n=115 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Death or Neurodevelopmental Impairment (NDI)
No
|
44 Participants
|
46 Participants
|
27 Participants
|
28 Participants
|
|
Death or Neurodevelopmental Impairment (NDI)
Yes
|
97 Participants
|
108 Participants
|
66 Participants
|
87 Participants
|
SECONDARY outcome
Timeframe: by 18-22 months corrected agePopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Death by 18-22 months corrected age
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=146 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=162 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Death
No
|
105 Participants
|
114 Participants
|
—
|
—
|
|
Death
Yes
|
41 Participants
|
48 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: by 18-22 months corrected agePopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, survived until follow-up visit at 18-22 months, and provided sufficient information to determine if NDI occurred.
NDI at 18-22 months corrected age (among survivors)
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=100 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=106 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Survival With Neurodevelopmental Impairment (NDI)
No
|
44 Participants
|
46 Participants
|
—
|
—
|
|
Survival With Neurodevelopmental Impairment (NDI)
Yes
|
56 Participants
|
60 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: up to the follow-up visit completed within the 18-22 months corrected age windowPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Death within 18-22 months corrected age or moderate to severe cerebral palsy at 18-22 months corrected age
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=142 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=157 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Death or Moderate to Severe Cerebral Palsy
No
|
84 Participants
|
78 Participants
|
—
|
—
|
|
Death or Moderate to Severe Cerebral Palsy
Yes
|
58 Participants
|
79 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: up to the follow-up visit completed within the 18-22 months corrected age windowPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Death within 18-22 months corrected age or Bayley cognitive composite score less than 85 at 18-22 months corrected age. Higher values of the Bayley cognitive composite score is better than lower values. Normal values are greater than or equal to 85. A moderate value is in the 70-84 range, and a severe value is \<70.
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=141 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=151 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Death or Bayley Cognitive Composite Score Less Than 85
No
|
46 Participants
|
51 Participants
|
—
|
—
|
|
Death or Bayley Cognitive Composite Score Less Than 85
Yes
|
95 Participants
|
100 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: up to the follow-up visit completed within the 18-22 months corrected age windowPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Death within 18-22 months corrected age or blindness at 18-22 months corrected age
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=142 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=157 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Death or Blindness
No
|
101 Participants
|
105 Participants
|
—
|
—
|
|
Death or Blindness
Yes
|
41 Participants
|
52 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: up to the follow-up visit completed within the 18-22 months corrected age windowPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Death within 18-22 months corrected age or hearing loss at 18-22 months corrected age
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=141 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=156 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Death or Hearing Loss
No
|
98 Participants
|
105 Participants
|
—
|
—
|
|
Death or Hearing Loss
Yes
|
43 Participants
|
51 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: between initial surgery and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birthPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Subsequent laparotomy after initial surgery
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=145 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=162 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Subsequent Laparotomy
No
|
110 Participants
|
81 Participants
|
—
|
—
|
|
Subsequent Laparotomy
Yes
|
35 Participants
|
81 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birthPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Any intraoperative complications during any surgery
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=145 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=162 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Any Intraoperative Complications During Any Surgery
No
|
116 Participants
|
141 Participants
|
—
|
—
|
|
Any Intraoperative Complications During Any Surgery
Yes
|
29 Participants
|
21 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birthPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Any wound dehiscence during any surgery
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=146 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=162 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Any Wound Dehiscence
No
|
135 Participants
|
154 Participants
|
—
|
—
|
|
Any Wound Dehiscence
Yes
|
11 Participants
|
8 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birthPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Any intra-abdominal abscess during any surgery
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=146 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=162 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Any Intra-abdominal Abscess
No
|
141 Participants
|
158 Participants
|
—
|
—
|
|
Any Intra-abdominal Abscess
Yes
|
5 Participants
|
4 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birthPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Any intestinal stricture during any surgery
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=146 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=162 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Any Intestinal Stricture
No
|
139 Participants
|
153 Participants
|
—
|
—
|
|
Any Intestinal Stricture
Yes
|
7 Participants
|
9 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birthPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Any late onset sepsis after randomization
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=146 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=160 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Any Late Onset Sepsis
No
|
123 Participants
|
126 Participants
|
—
|
—
|
|
Any Late Onset Sepsis
Yes
|
23 Participants
|
34 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birthPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Any Parenteral nutrition (PN)-associated cholestasis during any surgery
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=146 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=162 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Any Parenteral Nutrition (PN)-Associated Cholestasis
No
|
110 Participants
|
116 Participants
|
—
|
—
|
|
Any Parenteral Nutrition (PN)-Associated Cholestasis
Yes
|
36 Participants
|
46 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birthPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Any severe IVH ater randomization
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=140 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=157 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Any Severe IVH
Yes
|
18 Participants
|
25 Participants
|
—
|
—
|
|
Any Severe IVH
No
|
122 Participants
|
132 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birthPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Duration of mechanical ventilation while on study
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=107 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=120 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Duration of Mechanical Ventilation
|
33.3 days
Standard Deviation 25.6
|
38.9 days
Standard Deviation 26.7
|
—
|
—
|
SECONDARY outcome
Timeframe: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birthPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Duration of parenteral nutrition while on study
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=135 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=149 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Duration of Parenteral Nutrition
|
55.5 days
Standard Deviation 34.1
|
64.1 days
Standard Deviation 36.4
|
—
|
—
|
SECONDARY outcome
Timeframe: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birthPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Final bowel length after last surgery
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=28 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=16 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Final Bowel Length
|
74.4 cm
Standard Deviation 24.6
|
68.7 cm
Standard Deviation 35.7
|
—
|
—
|
SECONDARY outcome
Timeframe: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birthPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Time to full feeds while on study
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=92 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=92 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Time to Full Feeds
|
46.9 days
Standard Deviation 45.8
|
50.6 days
Standard Deviation 27.7
|
—
|
—
|
SECONDARY outcome
Timeframe: from randomization up to 1 year following birthPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Length of hospital stay while on study
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=137 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=156 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Length of Hospital Stay
|
101.2 days
Standard Deviation 71.2
|
113.8 days
Standard Deviation 73.8
|
—
|
—
|
SECONDARY outcome
Timeframe: at 18-22 months corrected agePopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Death or NDI at 18-22 months corrected age. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=141 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=154 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Death or NDI Stratified by Pre-operative Diagnosis
IP · No
|
31 Participants
|
38 Participants
|
—
|
—
|
|
Death or NDI Stratified by Pre-operative Diagnosis
IP · Yes
|
68 Participants
|
64 Participants
|
—
|
—
|
|
Death or NDI Stratified by Pre-operative Diagnosis
NEC · No
|
13 Participants
|
8 Participants
|
—
|
—
|
|
Death or NDI Stratified by Pre-operative Diagnosis
NEC · Yes
|
29 Participants
|
44 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: by 18-22 months corrected agePopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Death within 18-22 months corrected age. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=146 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=162 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Death Stratified by Pre-operative Diagnosis
NEC · Yes
|
17 Participants
|
27 Participants
|
—
|
—
|
|
Death Stratified by Pre-operative Diagnosis
IP · No
|
80 Participants
|
88 Participants
|
—
|
—
|
|
Death Stratified by Pre-operative Diagnosis
IP · Yes
|
24 Participants
|
21 Participants
|
—
|
—
|
|
Death Stratified by Pre-operative Diagnosis
NEC · No
|
25 Participants
|
26 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: by 18-22 months corrected agePopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, survived until follow-up visit at 18-22 months, and provided sufficient information to determine if NDI occurred.
NDI at 18-22 months corrected age (among survivors). Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=100 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=106 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Survival With Neurodevelopmental Impairment (NDI) Stratified by Pre-operative Diagnosis
IP · No
|
31 Participants
|
38 Participants
|
—
|
—
|
|
Survival With Neurodevelopmental Impairment (NDI) Stratified by Pre-operative Diagnosis
IP · Yes
|
44 Participants
|
43 Participants
|
—
|
—
|
|
Survival With Neurodevelopmental Impairment (NDI) Stratified by Pre-operative Diagnosis
NEC · No
|
13 Participants
|
8 Participants
|
—
|
—
|
|
Survival With Neurodevelopmental Impairment (NDI) Stratified by Pre-operative Diagnosis
NEC · Yes
|
12 Participants
|
17 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: up to the follow-up visit completed within the 18-22 months corrected age windowPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Death within 18-22 months corrected age or moderate to severe cerebral palsy at 18-22 months corrected age. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=142 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=157 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Death or Moderate to Severe Cerebral Palsy Stratified by Pre-operative Diagnosis
IP · No
|
64 Participants
|
64 Participants
|
—
|
—
|
|
Death or Moderate to Severe Cerebral Palsy Stratified by Pre-operative Diagnosis
IP · Yes
|
36 Participants
|
41 Participants
|
—
|
—
|
|
Death or Moderate to Severe Cerebral Palsy Stratified by Pre-operative Diagnosis
NEC · No
|
20 Participants
|
14 Participants
|
—
|
—
|
|
Death or Moderate to Severe Cerebral Palsy Stratified by Pre-operative Diagnosis
NEC · Yes
|
22 Participants
|
38 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: up to the follow-up visit completed within the 18-22 months corrected age windowPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Death within 18-22 months corrected age or Bayley cognitive composite score less than 85 at 18-22 months corrected age. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP). Higher values of the Bayley cognitive composite score is better than lower values. Normal values are greater than or equal to 85. A moderate value is in the 70-84 range, and a severe value is \<70.
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=141 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=151 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Death or Bayley Cognitive Composite Score Less Than 85 Stratified by Pre-operative Diagnosis
NEC · Yes
|
28 Participants
|
41 Participants
|
—
|
—
|
|
Death or Bayley Cognitive Composite Score Less Than 85 Stratified by Pre-operative Diagnosis
IP · No
|
32 Participants
|
42 Participants
|
—
|
—
|
|
Death or Bayley Cognitive Composite Score Less Than 85 Stratified by Pre-operative Diagnosis
IP · Yes
|
67 Participants
|
59 Participants
|
—
|
—
|
|
Death or Bayley Cognitive Composite Score Less Than 85 Stratified by Pre-operative Diagnosis
NEC · No
|
14 Participants
|
9 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: up to the follow-up visit completed within the 18-22 months corrected age windowPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Death within 18-22 months corrected age or blindness at 18-22 months corrected age. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=142 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=157 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Death or Blindness Stratified by Pre-operative Diagnosis
IP · No
|
76 Participants
|
83 Participants
|
—
|
—
|
|
Death or Blindness Stratified by Pre-operative Diagnosis
NEC · Yes
|
17 Participants
|
30 Participants
|
—
|
—
|
|
Death or Blindness Stratified by Pre-operative Diagnosis
IP · Yes
|
24 Participants
|
22 Participants
|
—
|
—
|
|
Death or Blindness Stratified by Pre-operative Diagnosis
NEC · No
|
25 Participants
|
22 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: up to the follow-up visit completed within the 18-22 months corrected age windowPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Death within 18-22 months corrected age or hearing loss at 18-22 months corrected age. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=141 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=156 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Death or Hearing Loss Stratified by Pre-operative Diagnosis
IP · No
|
73 Participants
|
81 Participants
|
—
|
—
|
|
Death or Hearing Loss Stratified by Pre-operative Diagnosis
IP · Yes
|
26 Participants
|
23 Participants
|
—
|
—
|
|
Death or Hearing Loss Stratified by Pre-operative Diagnosis
NEC · No
|
25 Participants
|
24 Participants
|
—
|
—
|
|
Death or Hearing Loss Stratified by Pre-operative Diagnosis
NEC · Yes
|
17 Participants
|
28 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birthPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Subsequent laparotomy after initial surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=145 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=162 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Subsequent Laparotomy Stratified by Pre-operative Diagnosis
IP · No
|
81 Participants
|
58 Participants
|
—
|
—
|
|
Subsequent Laparotomy Stratified by Pre-operative Diagnosis
IP · Yes
|
23 Participants
|
51 Participants
|
—
|
—
|
|
Subsequent Laparotomy Stratified by Pre-operative Diagnosis
NEC · No
|
29 Participants
|
23 Participants
|
—
|
—
|
|
Subsequent Laparotomy Stratified by Pre-operative Diagnosis
NEC · Yes
|
12 Participants
|
30 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birthPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Any intraoperative complications during any surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=145 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=162 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Any Intraoperative Complications During Any Surgery Stratified by Pre-operative Diagnosis
IP · No
|
83 Participants
|
95 Participants
|
—
|
—
|
|
Any Intraoperative Complications During Any Surgery Stratified by Pre-operative Diagnosis
IP · Yes
|
21 Participants
|
14 Participants
|
—
|
—
|
|
Any Intraoperative Complications During Any Surgery Stratified by Pre-operative Diagnosis
NEC · No
|
33 Participants
|
46 Participants
|
—
|
—
|
|
Any Intraoperative Complications During Any Surgery Stratified by Pre-operative Diagnosis
NEC · Yes
|
8 Participants
|
7 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birthPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Any wound dehiscence during any surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=146 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=162 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Any Wound Dehiscence Stratified by Pre-operative Diagnosis
IP · No
|
99 Participants
|
104 Participants
|
—
|
—
|
|
Any Wound Dehiscence Stratified by Pre-operative Diagnosis
IP · Yes
|
5 Participants
|
5 Participants
|
—
|
—
|
|
Any Wound Dehiscence Stratified by Pre-operative Diagnosis
NEC · No
|
36 Participants
|
50 Participants
|
—
|
—
|
|
Any Wound Dehiscence Stratified by Pre-operative Diagnosis
NEC · Yes
|
6 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birthPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Any intra-abdominal abscess during any surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=146 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=162 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Any Intra-abdominal Abscess Stratified by Pre-operative Diagnosis
NEC · No
|
40 Participants
|
52 Participants
|
—
|
—
|
|
Any Intra-abdominal Abscess Stratified by Pre-operative Diagnosis
NEC · Yes
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Any Intra-abdominal Abscess Stratified by Pre-operative Diagnosis
IP · No
|
101 Participants
|
106 Participants
|
—
|
—
|
|
Any Intra-abdominal Abscess Stratified by Pre-operative Diagnosis
IP · Yes
|
3 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birthPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Any intestinal stricture during any surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=146 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=162 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Any Intestinal Stricture Stratified by Pre-operative Diagnosis
IP · No
|
101 Participants
|
103 Participants
|
—
|
—
|
|
Any Intestinal Stricture Stratified by Pre-operative Diagnosis
IP · Yes
|
3 Participants
|
6 Participants
|
—
|
—
|
|
Any Intestinal Stricture Stratified by Pre-operative Diagnosis
NEC · No
|
38 Participants
|
50 Participants
|
—
|
—
|
|
Any Intestinal Stricture Stratified by Pre-operative Diagnosis
NEC · Yes
|
4 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birthPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Any late onset sepsis after randomization. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=146 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=160 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Any Late Onset Sepsis Stratified by Pre-operative Diagnosis
IP · No
|
88 Participants
|
80 Participants
|
—
|
—
|
|
Any Late Onset Sepsis Stratified by Pre-operative Diagnosis
IP · Yes
|
16 Participants
|
27 Participants
|
—
|
—
|
|
Any Late Onset Sepsis Stratified by Pre-operative Diagnosis
NEC · No
|
35 Participants
|
46 Participants
|
—
|
—
|
|
Any Late Onset Sepsis Stratified by Pre-operative Diagnosis
NEC · Yes
|
7 Participants
|
7 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birthPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Any Parenteral nutrition (PN)-associated cholestasis during any surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=146 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=162 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Any Parenteral Nutrition (PN)-Associated Cholestasis Stratified by Pre-operative Diagnosis
IP · No
|
79 Participants
|
82 Participants
|
—
|
—
|
|
Any Parenteral Nutrition (PN)-Associated Cholestasis Stratified by Pre-operative Diagnosis
IP · Yes
|
25 Participants
|
27 Participants
|
—
|
—
|
|
Any Parenteral Nutrition (PN)-Associated Cholestasis Stratified by Pre-operative Diagnosis
NEC · No
|
31 Participants
|
34 Participants
|
—
|
—
|
|
Any Parenteral Nutrition (PN)-Associated Cholestasis Stratified by Pre-operative Diagnosis
NEC · Yes
|
11 Participants
|
19 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birthPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Any severe IVH ater randomization. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=140 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=157 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Any Severe IVH Stratified by Pre-operative Diagnosis
IP · No
|
84 Participants
|
84 Participants
|
—
|
—
|
|
Any Severe IVH Stratified by Pre-operative Diagnosis
IP · Yes
|
17 Participants
|
22 Participants
|
—
|
—
|
|
Any Severe IVH Stratified by Pre-operative Diagnosis
NEC · No
|
38 Participants
|
48 Participants
|
—
|
—
|
|
Any Severe IVH Stratified by Pre-operative Diagnosis
NEC · Yes
|
1 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birthPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Duration of mechanical ventilation while on study. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=107 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=120 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Duration of Mechanical Ventilation Stratified by Pre-operative Diagnosis
IP
|
34.1 days
Standard Deviation 26.6
|
42.2 days
Standard Deviation 28
|
—
|
—
|
|
Duration of Mechanical Ventilation Stratified by Pre-operative Diagnosis
NEC
|
31 days
Standard Deviation 22.6
|
31.7 days
Standard Deviation 22.5
|
—
|
—
|
SECONDARY outcome
Timeframe: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birthPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Duration of parenteral nutrition while on study. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=135 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=149 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Duration of Parenteral Nutrition Stratified by Pre-operative Diagnosis
IP
|
56.3 days
Standard Deviation 35.2
|
63.6 days
Standard Deviation 33.7
|
—
|
—
|
|
Duration of Parenteral Nutrition Stratified by Pre-operative Diagnosis
NEC
|
53.5 days
Standard Deviation 31.3
|
65.3 days
Standard Deviation 42
|
—
|
—
|
SECONDARY outcome
Timeframe: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birthPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Final bowel length after last surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=28 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=16 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Final Bowel Length Stratified by Pre-operative Diagnosis
IP
|
83.1 cm
Standard Deviation 20.9
|
74.7 cm
Standard Deviation 22.4
|
—
|
—
|
|
Final Bowel Length Stratified by Pre-operative Diagnosis
NEC
|
62.7 cm
Standard Deviation 25
|
64 cm
Standard Deviation 44.2
|
—
|
—
|
SECONDARY outcome
Timeframe: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birthPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Time to full feeds while on study. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=92 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=92 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Time to Full Feeds Stratified by Pre-operative Diagnosis
IP
|
52.4 days
Standard Deviation 50.4
|
56.3 days
Standard Deviation 27.1
|
—
|
—
|
|
Time to Full Feeds Stratified by Pre-operative Diagnosis
NEC
|
29.6 days
Standard Deviation 18.9
|
32.3 days
Standard Deviation 21.3
|
—
|
—
|
SECONDARY outcome
Timeframe: from randomization up to 1 year following birthPopulation: Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization.
Length of hospital stay while on study. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Outcome measures
| Measure |
Randomized Trial: Initial Laparotomy
n=137 Participants
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=156 Participants
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Laparotomy
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Length of Hospital Stay Stratified by Pre-operative Diagnosis
IP
|
109.6 days
Standard Deviation 67
|
121.3 days
Standard Deviation 64.7
|
—
|
—
|
|
Length of Hospital Stay Stratified by Pre-operative Diagnosis
NEC
|
80.2 days
Standard Deviation 77.8
|
99.2 days
Standard Deviation 87.7
|
—
|
—
|
Adverse Events
Randomized Trial: Initial Laparotomy
Serious events: 41 serious events
Other events: 0 other events
Deaths: 41 deaths
Randomized Trial: Initial Peritoneal Drain
Serious events: 49 serious events
Other events: 0 other events
Deaths: 48 deaths
Preference Cohort: Initial Laparotomy
Serious events: 49 serious events
Other events: 0 other events
Deaths: 48 deaths
Preference Cohort: Initial Peritoneal Drain
Serious events: 60 serious events
Other events: 0 other events
Deaths: 60 deaths
Serious adverse events
| Measure |
Randomized Trial: Initial Laparotomy
n=146 participants at risk
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Randomized Trial: Initial Peritoneal Drain
n=162 participants at risk
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
Preference Cohort: Initial Laparotomy
n=100 participants at risk
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
|
Preference Cohort: Initial Peritoneal Drain
n=119 participants at risk
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
|
|---|---|---|---|---|
|
Cardiac disorders
Pericardial effusion
|
0.68%
1/146 • Number of events 1 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/162 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/100 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/119 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
|
Gastrointestinal disorders
Abdominal herniation
|
0.00%
0/146 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.62%
1/162 • Number of events 1 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/100 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/119 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
|
Gastrointestinal disorders
Neonatal spontaneous intestinal perforation
|
2.1%
3/146 • Number of events 3 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/162 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
2.0%
2/100 • Number of events 2 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
7.6%
9/119 • Number of events 9 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
|
Gastrointestinal disorders
Necrotizing enterocolitis neonatal
|
14.4%
21/146 • Number of events 21 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
14.8%
24/162 • Number of events 24 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
35.0%
35/100 • Number of events 35 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
21.0%
25/119 • Number of events 25 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dysplasia
|
0.68%
1/146 • Number of events 1 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
1.2%
2/162 • Number of events 2 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
1.0%
1/100 • Number of events 1 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
1.7%
2/119 • Number of events 2 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
|
Nervous system disorders
CNS injury
|
0.00%
0/146 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.62%
1/162 • Number of events 1 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/100 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/119 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
|
Infections and infestations
Neonatal sepsis
|
6.8%
10/146 • Number of events 10 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
9.9%
16/162 • Number of events 16 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
13.0%
13/100 • Number of events 13 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
7.6%
9/119 • Number of events 9 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress syndrome
|
2.1%
3/146 • Number of events 3 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.62%
1/162 • Number of events 1 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/100 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
5.9%
7/119 • Number of events 7 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
|
Nervous system disorders
Intracranial hemorrhage
|
2.7%
4/146 • Number of events 4 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.62%
1/162 • Number of events 1 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/100 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
2.5%
3/119 • Number of events 3 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
|
General disorders
Death
|
2.7%
4/146 • Number of events 4 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
6.8%
11/162 • Number of events 11 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
6.0%
6/100 • Number of events 6 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
6.7%
8/119 • Number of events 8 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
|
Infections and infestations
Fungal Infection
|
0.00%
0/146 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.62%
1/162 • Number of events 1 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/100 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/119 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
|
Pregnancy, puerperium and perinatal conditions
Prematurity
|
2.1%
3/146 • Number of events 3 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.62%
1/162 • Number of events 1 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/100 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
1.7%
2/119 • Number of events 2 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal pneumothorax
|
0.00%
0/146 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
1.2%
2/162 • Number of events 2 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/100 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/119 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal pulmonary haemorrhage
|
0.68%
1/146 • Number of events 1 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/162 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
1.0%
1/100 • Number of events 1 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.84%
1/119 • Number of events 1 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/146 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.62%
1/162 • Number of events 1 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/100 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
1.7%
2/119 • Number of events 2 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/146 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/162 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/100 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.84%
1/119 • Number of events 1 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/146 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/162 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
1.0%
1/100 • Number of events 1 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/119 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
|
Infections and infestations
Neonatal infection
|
0.68%
1/146 • Number of events 1 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
1.2%
2/162 • Number of events 2 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/100 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
5.9%
7/119 • Number of events 7 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
|
Renal and urinary disorders
Renal failure neonatal
|
0.00%
0/146 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.62%
1/162 • Number of events 1 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/100 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/119 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
|
Gastrointestinal disorders
Intra-abdominal bleeding
|
0.68%
1/146 • Number of events 1 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/162 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/100 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/119 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
|
General disorders
Multiorgan failure
|
0.68%
1/146 • Number of events 1 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.62%
1/162 • Number of events 1 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/100 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/119 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
|
Blood and lymphatic system disorders
Coagulopathies
|
0.00%
0/146 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/162 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
1.0%
1/100 • Number of events 1 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/119 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
|
Nervous system disorders
Intraventricular haemorrhage neonatal
|
0.00%
0/146 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.00%
0/162 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
1.0%
1/100 • Number of events 1 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
0.84%
1/119 • Number of events 1 • Adverse events are monitored from randomization through study status (death, discharge or 120 days)
|
Other adverse events
Adverse event data not reported
Additional Information
Martin L Blakely, MD
Vanderbilt University Medical Center
Phone: 615-936-7211
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators must adhere to the Neonatal Research Network Publication policies.
- Publication restrictions are in place
Restriction type: OTHER