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=5 Participants	72.7 hours STANDARD_DEVIATION 25.2 • n=7 Participants	67.4 hours STANDARD_DEVIATION 22.1 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants	26 Participants n=7 Participants	57 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants	38 participants n=7 Participants	77 participants n=5 Participants
Birth Weight	1792 grams STANDARD_DEVIATION 513 • n=5 Participants	1933 grams STANDARD_DEVIATION 315 • n=7 Participants	1862 grams STANDARD_DEVIATION 415 • n=5 Participants
First observed total bilirubin	8.1 mg/dL STANDARD_DEVIATION 3.0 • n=5 Participants	8.3 mg/dL STANDARD_DEVIATION 3.3 • n=7 Participants	8.2 mg/dL STANDARD_DEVIATION 3.1 • n=5 Participants
Gestation age	33.2 weeks STANDARD_DEVIATION 1.4 • n=5 Participants	33.0 weeks STANDARD_DEVIATION 1.1 • n=7 Participants	33.1 weeks STANDARD_DEVIATION 1.3 • n=5 Participants
Feeding stratum NPO	18 participants n=5 Participants	16 participants n=7 Participants	34 participants n=5 Participants
Feeding stratum PO-formula	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants
Feeding stratum PO -breastmilk	7 participants n=5 Participants	6 participants n=7 Participants	13 participants n=5 Participants
Feeding stratum PO-both formula and breastmilk	8 participants n=5 Participants	10 participants n=7 Participants	18 participants n=5 Participants

PRIMARY outcome

Timeframe: from time of enrollment to time of discharge, for a maximum of 10 weeks

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.
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 weeks

Bilirubin 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 weeks

Bilirubin 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 weeks

Absolute 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 weeks

time 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

Carl D'Angio

University of Rochester

Phone: 585-273-4911

Email: carol_dangio@urmc.rochester.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place