Trial · NCT01746511
Glycerin Suppositories to Reduce Jaundice in Premature Infants
NCT01746511, Not applicable, Completed, University of Rochester; results first posted 2015-12-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Glycerin Suppositories to Reduce Jaundice in Premature Infants. Trials, record NCT01746511. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01746511
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Glycerin Suppositories to Reduce Jaundice in Premature Infants
- NCT number
- NCT01746511
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 79 participants, actual
- Lead sponsor
- University of Rochester
- Conditions
- Idiopathic Hyperbilirubinemia, Neonatal Hyperbilirubinemia, Prematurity
- Interventions
- Phototherapy, glycerin suppository
- First posted
- 2012-12-11
- Last updated
- 2015-12-09
- Results first posted
- 2015-12-09
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Number of Hours of Required Phototherapy | from time of enrollment to time of discharge, for a maximum of 10 weeks | |
| Secondary | Number of Episodes of Repeat Phototherapy | 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. |
| Secondary | Peak Total Serum Bilirubin Level | 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. |
| Secondary | Rate of Decline in Bilirubin Levels (mg/dL/hr) | 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 |
| Secondary | Length of Initial Round of Phototherapy | 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 |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Number of Hours of Required Phototherapy | from time of enrollment to time of discharge, for a maximum of 10 weeks | hours | MEAN | |
| SECONDARY | Number of Episodes of Repeat Phototherapy | from time of enrollment to time of discharge, for a maximum of 10 weeks | episodes of repeat phototherapy | MEDIAN | |
| SECONDARY | Peak Total Serum Bilirubin Level | from time of enrollment to time of discharge every 12 hours while under phototherapy, for a maximum of 10 weeks | mg/dL | MEAN | |
| SECONDARY | Rate of Decline in Bilirubin Levels (mg/dL/hr) | from time of enrollment to time of discharge, for a maximum of 10 weeks | mg/dL/hr | MEAN | |
| SECONDARY | Length of Initial Round of Phototherapy | from time of enrollment to time of discharge, for a maximum of 10 weeks | hours | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Number of Hours of Required Phototherapy | Glycerin Suppository | 72 | Standard Deviation 49 | hours | |
| Total Number of Hours of Required Phototherapy | No Glycerin Suppository | 61 | Standard Deviation 53 | hours | |
| Number of Episodes of Repeat Phototherapy | Glycerin Suppository | 0 | Full Range 0 to 7 | episodes of repeat phototherapy | |
| Number of Episodes of Repeat Phototherapy | No Glycerin Suppository | 0 | Full Range 0 to 7 | episodes of repeat phototherapy | |
| Peak Total Serum Bilirubin Level | Glycerin Suppository | 11.3 | Standard Deviation 1.8 | mg/dL | |
| Peak Total Serum Bilirubin Level | No Glycerin Suppository | 12.0 | Standard Deviation 1.5 | mg/dL | |
| Rate of Decline in Bilirubin Levels (mg/dL/hr) | Glycerin Suppository | 0.4 | Standard Deviation 0.2 | mg/dL/hr | |
| Rate of Decline in Bilirubin Levels (mg/dL/hr) | No Glycerin Suppository | 0.4 | Standard Deviation 0.1 | mg/dL/hr | |
| Length of Initial Round of Phototherapy | Glycerin Suppository | 118 | Standard Deviation 128 | hours | |
| Length of Initial Round of Phototherapy | No Glycerin Suppository | 81 | Standard Deviation 85 | hours |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Glycerin Suppository | 40 | |
| Overall Study | STARTED | No Glycerin Suppository | 39 | |
| Overall Study | COMPLETED | Glycerin Suppository | 40 | |
| Overall Study | COMPLETED | No Glycerin Suppository | 39 | |
| Overall Study | NOT COMPLETED | Glycerin Suppository | 0 | |
| Overall Study | NOT COMPLETED | No Glycerin Suppository | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bloody Stool | Gastrointestinal disorders | Glycerin Suppository | 1 | 40 | 1 |
| other | Bloody Stool | Gastrointestinal disorders | No Glycerin Suppository | 0 | 39 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Glycerin Suppository | ||
| Total, all-cause mortality | No Glycerin Suppository | ||
| Total, other adverse events | Glycerin Suppository | 1 | 40 |
| Total, other adverse events | No Glycerin Suppository | 0 | 39 |
| Total, serious adverse events | Glycerin Suppository | 0 | 40 |
| Total, serious adverse events | No Glycerin Suppository | 0 | 39 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Glycerin Suppository vs No Glycerin Suppository: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01746511
GET https://conductscience.org/api/trials/v1/NCT01746511/registered