Trial Outcomes & Findings for Glycerin Suppositories to Reduce Jaundice in Premature Infants (NCT NCT01746511)
NCT ID: NCT01746511
Last Updated: 2015-12-09
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
79 participants
Primary outcome timeframe
from time of enrollment to time of discharge, for a maximum of 10 weeks
Results posted on
2015-12-09
Participant Flow
Participant milestones
| Measure |
Glycerin Suppository
Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
1. Infants who are NPO (\< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
2. Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.
glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams.
|
No Glycerin Suppository
Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
1. Infants who are NPO (\< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
2. Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
39
|
|
Overall Study
COMPLETED
|
40
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Glycerin Suppositories to Reduce Jaundice in Premature Infants
Baseline characteristics by cohort
| Measure |
Glycerin Suppository
n=39 Participants
Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
1. Infants who are NPO (\< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
2. Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.
glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams. All infants in this study arm will receive our
|
No Glycerin Suppository
n=38 Participants
Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
1. Infants who are NPO (\< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
2. Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.2 hours
STANDARD_DEVIATION 19.1 • n=99 Participants
|
72.7 hours
STANDARD_DEVIATION 25.2 • n=107 Participants
|
67.4 hours
STANDARD_DEVIATION 22.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=99 Participants
|
38 participants
n=107 Participants
|
77 participants
n=206 Participants
|
|
Birth Weight
|
1792 grams
STANDARD_DEVIATION 513 • n=99 Participants
|
1933 grams
STANDARD_DEVIATION 315 • n=107 Participants
|
1862 grams
STANDARD_DEVIATION 415 • n=206 Participants
|
|
First observed total bilirubin
|
8.1 mg/dL
STANDARD_DEVIATION 3.0 • n=99 Participants
|
8.3 mg/dL
STANDARD_DEVIATION 3.3 • n=107 Participants
|
8.2 mg/dL
STANDARD_DEVIATION 3.1 • n=206 Participants
|
|
Gestation age
|
33.2 weeks
STANDARD_DEVIATION 1.4 • n=99 Participants
|
33.0 weeks
STANDARD_DEVIATION 1.1 • n=107 Participants
|
33.1 weeks
STANDARD_DEVIATION 1.3 • n=206 Participants
|
|
Feeding stratum
NPO
|
18 participants
n=99 Participants
|
16 participants
n=107 Participants
|
34 participants
n=206 Participants
|
|
Feeding stratum
PO-formula
|
7 participants
n=99 Participants
|
7 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Feeding stratum
PO -breastmilk
|
7 participants
n=99 Participants
|
6 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Feeding stratum
PO-both formula and breastmilk
|
8 participants
n=99 Participants
|
10 participants
n=107 Participants
|
18 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: from time of enrollment to time of discharge, for a maximum of 10 weeksOutcome measures
| Measure |
Glycerin Suppository
n=40 Participants
Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
1. Infants who are NPO (\< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
2. Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.
glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams.
|
No Glycerin Suppository
n=39 Participants
Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
1. Infants who are NPO (\< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
2. Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.
|
|---|---|---|
|
Total Number of Hours of Required Phototherapy
|
72 hours
Standard Deviation 49
|
61 hours
Standard Deviation 53
|
SECONDARY outcome
Timeframe: from time of enrollment to time of discharge, for a maximum of 10 weeksBilirubin levels are checked at regular intervals after phototherapy is discontinued to make sure levels are safe. Depending on rate of rise and predetermined "unsafe" bilirubin level, phototherapy may be restarted.
Outcome measures
| Measure |
Glycerin Suppository
n=40 Participants
Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
1. Infants who are NPO (\< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
2. Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.
glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams.
|
No Glycerin Suppository
n=39 Participants
Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
1. Infants who are NPO (\< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
2. Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.
|
|---|---|---|
|
Number of Episodes of Repeat Phototherapy
|
0 episodes of repeat phototherapy
Interval 0.0 to 7.0
|
0 episodes of repeat phototherapy
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: from time of enrollment to time of discharge every 12 hours while under phototherapy, for a maximum of 10 weeksBilirubin levels were checked every 12 hours while the infant was under phototherapy. A bilirubin level was then to be checked at least twice, 8-12 hours or longer apart, following discontinuation of phototherapy.
Outcome measures
| Measure |
Glycerin Suppository
n=40 Participants
Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
1. Infants who are NPO (\< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
2. Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.
glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams.
|
No Glycerin Suppository
n=39 Participants
Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
1. Infants who are NPO (\< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
2. Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.
|
|---|---|---|
|
Peak Total Serum Bilirubin Level
|
11.3 mg/dL
Standard Deviation 1.8
|
12.0 mg/dL
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: from time of enrollment to time of discharge, for a maximum of 10 weeksAbsolute change over time from peak to first discontinuation of phototherapy lights
Outcome measures
| Measure |
Glycerin Suppository
n=40 Participants
Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
1. Infants who are NPO (\< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
2. Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.
glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams.
|
No Glycerin Suppository
n=39 Participants
Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
1. Infants who are NPO (\< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
2. Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.
|
|---|---|---|
|
Rate of Decline in Bilirubin Levels (mg/dL/hr)
|
0.4 mg/dL/hr
Standard Deviation 0.2
|
0.4 mg/dL/hr
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: from time of enrollment to time of discharge, for a maximum of 10 weekstime start to time finally off phototherapy, including any breaks during which they were off
Outcome measures
| Measure |
Glycerin Suppository
n=40 Participants
Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
1. Infants who are NPO (\< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
2. Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.
glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams.
|
No Glycerin Suppository
n=39 Participants
Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
1. Infants who are NPO (\< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
2. Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.
|
|---|---|---|
|
Length of Initial Round of Phototherapy
|
118 hours
Standard Deviation 128
|
81 hours
Standard Deviation 85
|
Adverse Events
Glycerin Suppository
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
No Glycerin Suppository
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Glycerin Suppository
n=40 participants at risk
Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
1. Infants who are NPO (\< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
2. Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.
glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams. All infants in this study arm will receive our
|
No Glycerin Suppository
n=39 participants at risk
Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).
Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:
1. Infants who are NPO (\< 20 mL/kg/day of fluids enterally at the time of therapy) vs.
2. Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.
|
|---|---|---|
|
Gastrointestinal disorders
Bloody Stool
|
2.5%
1/40 • Number of events 1
|
0.00%
0/39
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place