Trial Outcomes & Findings for Comparative Effectiveness Trial for Diagnosis of Necrotizing Enterocolitis (NCT NCT05573113)
NCT ID: NCT05573113
Last Updated: 2025-11-21
Results Overview
Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds
COMPLETED
NA
169 participants
Within 30 days of NEC concern
2025-11-21
Participant Flow
Conducted between Sept 2022 - Dec 2024 at two sites: Children's Mercy Hospital (Level IV NICU) and University of Kansas Medical Center (Level III NICU).
Randomization was conducted by calendar month (odd months = AXR only; even months = AXR + BUS). Cross-over occurred in 31 AXR-only evaluations (also received BUS) and 3 AXR+BUS evaluations (only received AXR). A total of 169 infants underwent 199 imaging evaluations for NEC.
Unit of analysis: Imaging evaluation for NEC
Participant milestones
| Measure |
Abdominal Radiographs Only (AXR)
Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs only (AXR)
|
Abdominal Radiographs plus Bowel Ultrasound (AXR + BUS)
Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs plus bowel ultrasound (AXR + BUS)
|
|---|---|---|
|
Overall Study
STARTED
|
92 114
|
77 85
|
|
Overall Study
Cross-Over
|
26 31
|
3 3
|
|
Overall Study
COMPLETED
|
92 114
|
77 85
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Effectiveness Trial for Diagnosis of Necrotizing Enterocolitis
Baseline characteristics by cohort
| Measure |
Abdominal Radiographs Only (AXR)
n=92 Participants
Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs only (AXR)
|
Abdominal Radiographs Plus Bowel Ultrasound (AXR + BUS)
n=77 Participants
Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs plus bowel ultrasound (AXR + BUS)
|
Total
n=169 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31 weeks
STANDARD_DEVIATION 4.8 • n=39 Participants
|
31 weeks
STANDARD_DEVIATION 5.2 • n=29 Participants
|
31 weeks
STANDARD_DEVIATION 5 • n=60 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=39 Participants
|
19 Participants
n=29 Participants
|
56 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=39 Participants
|
58 Participants
n=29 Participants
|
113 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=39 Participants
|
4 Participants
n=29 Participants
|
7 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=39 Participants
|
18 Participants
n=29 Participants
|
39 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=39 Participants
|
40 Participants
n=29 Participants
|
86 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=39 Participants
|
15 Participants
n=29 Participants
|
37 Participants
n=60 Participants
|
|
Birthweight
|
1.63 kg
STANDARD_DEVIATION 0.86 • n=39 Participants
|
1.66 kg
STANDARD_DEVIATION 1.10 • n=29 Participants
|
1.64 kg
STANDARD_DEVIATION 0.97 • n=60 Participants
|
|
Site - Level III or IV NICU
Level III
|
37 Participants
n=39 Participants
|
27 Participants
n=29 Participants
|
64 Participants
n=60 Participants
|
|
Site - Level III or IV NICU
Level IV
|
55 Participants
n=39 Participants
|
50 Participants
n=29 Participants
|
105 Participants
n=60 Participants
|
|
Multiple Gestation (%)
|
18 Participants
n=39 Participants
|
17 Participants
n=29 Participants
|
35 Participants
n=60 Participants
|
|
Congenital anomalies (%)
|
19 Participants
n=39 Participants
|
9 Participants
n=29 Participants
|
28 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: Within 30 days of NEC concernPopulation: Extended Rule Out Group: Infants with clinical concern for NEC who were ultimately not diagnosed with NEC but required more than one AXR to confidently rule out the disease. Infants who crossed over to a different imaging strategy were analyzed according to the arm to which they were originally randomized, following an intention-to-treat approach.
Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds
Outcome measures
| Measure |
Abdominal Radiographs Only (AXR)
n=42 Participants
Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs only (AXR)
|
Abdominal Radiographs plus Bowel Ultrasound (AXR + BUS)
n=28 Participants
Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs plus bowel ultrasound (AXR + BUS)
|
|---|---|---|
|
Days to Full Enteral Feeds: Extended Rule Out Group
|
10.1 days
Standard Deviation 10.9
|
4.9 days
Standard Deviation 4.5
|
PRIMARY outcome
Timeframe: Within 30 days of NEC concernPopulation: Quick Rule Out Group: Infants with suspected NEC in whom the diagnosis was excluded after a single AXR. Infants who crossed over to a different imaging strategy were analyzed according to the arm to which they were originally randomized, following an intention-to-treat approach.
Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds
Outcome measures
| Measure |
Abdominal Radiographs Only (AXR)
n=40 Participants
Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs only (AXR)
|
Abdominal Radiographs plus Bowel Ultrasound (AXR + BUS)
n=23 Participants
Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs plus bowel ultrasound (AXR + BUS)
|
|---|---|---|
|
Days to Full Enteral Feeds: Quick Rule Out Group
|
0.4 days
Standard Deviation 1.4
|
1.0 days
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: Within 30 days of NEC concernPopulation: NEC Ruled In Group: Infants with suspected NEC who were diagnosed with NEC based on clinical, laboratory, and imaging findings. Infants who crossed over to a different imaging strategy were analyzed according to the arm to which they were originally randomized, following an intention-to-treat approach.
Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds
Outcome measures
| Measure |
Abdominal Radiographs Only (AXR)
n=32 Participants
Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs only (AXR)
|
Abdominal Radiographs plus Bowel Ultrasound (AXR + BUS)
n=34 Participants
Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs plus bowel ultrasound (AXR + BUS)
|
|---|---|---|
|
Days to Full Enteral Feeds: NEC Ruled In
|
17.0 days
Standard Deviation 8.6
|
17.6 days
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: within 14 days of NEC concernPopulation: Extended Rule Out Group: Infants with clinical concern for NEC who were ultimately not diagnosed with NEC but required more than one AXR to confidently rule out the disease. Infants who crossed over to a different imaging strategy were analyzed according to the arm to which they were originally randomized, following an intention-to-treat approach.
Number of days infants were kept nil per os (without enteral feeds) following concern for NEC
Outcome measures
| Measure |
Abdominal Radiographs Only (AXR)
n=42 Participants
Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs only (AXR)
|
Abdominal Radiographs plus Bowel Ultrasound (AXR + BUS)
n=28 Participants
Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs plus bowel ultrasound (AXR + BUS)
|
|---|---|---|
|
Days to End Bowel Rest: Extended Rule Out Group
|
2.6 days
Standard Deviation 2.9
|
2.1 days
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: within 14 days of NEC concernPopulation: Quick Rule Out Group: Infants with suspected NEC in whom the diagnosis was excluded after a single AXR. Infants who crossed over to a different imaging strategy were analyzed according to the arm to which they were originally randomized, following an intention-to-treat approach.
Number of days infants were kept nil per os (without enteral feeds) following concern for NEC
Outcome measures
| Measure |
Abdominal Radiographs Only (AXR)
n=40 Participants
Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs only (AXR)
|
Abdominal Radiographs plus Bowel Ultrasound (AXR + BUS)
n=23 Participants
Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs plus bowel ultrasound (AXR + BUS)
|
|---|---|---|
|
Days to End Bowel Rest: Quick Rule Out Group
|
0.2 days
Standard Deviation 0.6
|
0.4 days
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: within 14 days of NEC concernPopulation: NEC Ruled In Group: Infants with suspected NEC who were diagnosed with NEC based on clinical, laboratory, and imaging findings. Infants who crossed over to a different imaging strategy were analyzed according to the arm to which they were originally randomized, following an intention-to-treat approach.
Number of days infants were kept nil per os (without enteral feeds) following concern for NEC
Outcome measures
| Measure |
Abdominal Radiographs Only (AXR)
n=32 Participants
Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs only (AXR)
|
Abdominal Radiographs plus Bowel Ultrasound (AXR + BUS)
n=34 Participants
Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs plus bowel ultrasound (AXR + BUS)
|
|---|---|---|
|
Days to End Bowel Rest: NEC Ruled In
|
8.7 days
Standard Deviation 4.0
|
8.7 days
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: within 14 days of NEC concernPopulation: Extended Rule Out Group: Infants with clinical concern for NEC who were ultimately not diagnosed with NEC but required more than one AXR to confidently rule out the disease. Infants who crossed over to a different imaging strategy were analyzed according to the arm to which they were originally randomized, following an intention-to-treat approach.
Number of days infants received antibiotic therapy initiated for NEC concern
Outcome measures
| Measure |
Abdominal Radiographs Only (AXR)
n=42 Participants
Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs only (AXR)
|
Abdominal Radiographs plus Bowel Ultrasound (AXR + BUS)
n=28 Participants
Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs plus bowel ultrasound (AXR + BUS)
|
|---|---|---|
|
Days to End Antibiotics: Extended Rule Out
|
1.6 days
Standard Deviation 2.3
|
1.5 days
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: within 14 days of NEC concernPopulation: Quick Rule Out Group: Infants with suspected NEC in whom the diagnosis was excluded after a single AXR. Infants who crossed over to a different imaging strategy were analyzed according to the arm to which they were originally randomized, following an intention-to-treat approach.
Number of days infants received antibiotic therapy initiated for NEC concern
Outcome measures
| Measure |
Abdominal Radiographs Only (AXR)
n=40 Participants
Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs only (AXR)
|
Abdominal Radiographs plus Bowel Ultrasound (AXR + BUS)
n=23 Participants
Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs plus bowel ultrasound (AXR + BUS)
|
|---|---|---|
|
Days to End Antibiotics: Quick Rule Out
|
0.1 days
Standard Deviation 0.8
|
0.8 days
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: within 14 days of NEC concernPopulation: NEC Ruled In Group: Infants with suspected NEC who were diagnosed with NEC based on clinical, laboratory, and imaging findings. Infants who crossed over to a different imaging strategy were analyzed according to the arm to which they were originally randomized, following an intention-to-treat approach.
Number of days infants received antibiotic therapy initiated for NEC concern
Outcome measures
| Measure |
Abdominal Radiographs Only (AXR)
n=32 Participants
Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs only (AXR)
|
Abdominal Radiographs plus Bowel Ultrasound (AXR + BUS)
n=34 Participants
Infants with concern for necrotizing enterocolitis randomized to imaging with abdominal radiographs plus bowel ultrasound (AXR + BUS)
|
|---|---|---|
|
Days to End Antibiotics: NEC Rule In
|
8.4 days
Standard Deviation 4.0
|
7.5 days
Standard Deviation 3.2
|
Adverse Events
Abdominal Radiographs Only (AXR)
Abdominal Radiographs plus Bowel Ultrasound (AXR + BUS)
Cross-Over to AXR + BUS
Cross-Over to AXR only
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place