N/A
N=79
Glycerin Suppositories to Reduce Jaundice in Premature Infants
Idiopathic Hyperbilirubinemia · Neonatal Hyperbilirubinemia · Prematurity
Bottom Line
View on ClinicalTrials.gov: NCT01746511 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: Primary: Total Number of Hours of Required Phototherapy — 72; 61 hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Phototherapy (Procedure); glycerin suppository (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Hours of Required Phototherapy |
72; 61 | — |
| SECONDARY Number of Episodes of Repeat Phototherapy |
0; 0 | — |
| SECONDARY Peak Total Serum Bilirubin Level |
11.3; 12.0 | — |
| SECONDARY Rate of Decline in Bilirubin Levels (mg/dL/hr) |
0.4; 0.4 | — |
| SECONDARY Length of Initial Round of Phototherapy |
118; 81 | — |
Summary
The purpose of this study is to find out if giving glycerin suppositories will help decrease the length of time premature infants need phototherapy.
The investigators hypothesize that glycerin suppositories (initiated along with phototherapy) will have no effect on reducing duration of phototherapy in premature infants with jaundice.
Eligibility Criteria
Inclusion Criteria
- Baby born between 30 to 34 6/7 weeks gestational age (GA) at birth and admitted to NICU
- Baby with physiologic hyperbilirubinemia requiring phototherapy by current NICU criteria.
- Parental permission.
Exclusion Criteria
- Babies less than 30 weeks GA or greater than 34 6/7 weeks GA
- Non-physiologic hyperbilirubinemia: (1) positive Coombs test and (2) hematocrit < 5th percentile for GA (see Jopling J, Henry E, Wiedmeier SE, Christensen RD, Reference. Ranges for Hematocrit and Blood Hemoglobin Concentration During the Neonatal Period: Data From a Multihospital Health Care System. Pediatrics 2009; 123(2):e333 -e337.) and (3) ABO or Rh incompatibility.
- Any infant with bilirubin level within 2 mg/dL of exchange transfusion.
- Any infant who has phototherapy started prior to reaching light level (prophylactic)
- Baby with any GI abnormalities such as NEC, intestinal perforation, gastroschisis, omphalocele, malrotation and or volvulus, duodenal atresia, intestinal strictures/adhesions, imperforate anus.
- Any infant begun on triple or greater phototherapy at time of initiation of treatment.
- Any infant judged by the attending physician to be placed at increased risk by study participation.
Data sourced from ClinicalTrials.gov (NCT01746511). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.