Prematurity Clinical Trial
Official title:
The Use of Glycerin Suppositories to Reduce Hyperbilirubinemia in Premature Infants Requiring Phototherapy
Verified date | November 2015 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 79 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 30 Weeks to 35 Weeks |
Eligibility |
Inclusion Criteria: 1. Baby born between 30 to 34 6/7 weeks gestational age (GA) at birth and admitted to NICU 2. Baby with physiologic hyperbilirubinemia requiring phototherapy by current NICU criteria. 3. Parental permission. Exclusion Criteria: 1. Babies less than 30 weeks GA or greater than 34 6/7 weeks GA 2. 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. 3. Any infant with bilirubin level within 2 mg/dL of exchange transfusion. 4. Any infant who has phototherapy started prior to reaching light level (prophylactic) 5. Baby with any GI abnormalities such as NEC, intestinal perforation, gastroschisis, omphalocele, malrotation and or volvulus, duodenal atresia, intestinal strictures/adhesions, imperforate anus. 6. Any infant begun on triple or greater phototherapy at time of initiation of treatment. 7. Any infant judged by the attending physician to be placed at increased risk by study participation. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester Medical Center NICU | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester |
United States,
Amin, S. (2011). Personal communication.
Bader D, Yanir Y, Kugelman A, Wilhelm-Kafil M, Riskin A. Induction of early meconium evacuation: is it effective in reducing the level of neonatal hyperbilirubinemia? Am J Perinatol. 2005 Aug;22(6):329-33. — View Citation
Boyer DB, Vidyasagar D. Serum indirect bilirubin levels and meconium passage in early fed normal newborns. Nurs Res. 1987 May-Jun;36(3):174-8. — View Citation
Chen JY, Ling UP, Chen JH. Early meconium evacuation: effect on neonatal hyperbilirubinemia. Am J Perinatol. 1995 Jul;12(4):232-4. — View Citation
De Carvalho M, Robertson S, Klaus M. Fecal bilirubin excretion and serum bilirubin concentrations in breast-fed and bottle-fed infants. J Pediatr. 1985 Nov;107(5):786-90. — View Citation
Jirsová V, Janovský M. Hyperbilirubinemia connected with parenteral administration of higher amounts of fluids in premature infants. Biol Neonate. 1978;33(3-4):132-4. — View Citation
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 Feb;123(2):e333-7. doi: 10.1542/peds.2008-2654. — View Citation
Maisels MJ. Jaundice. In: Avery GB, Fletcher MA, MacDonald MG, eds. Neonatology: Pathophysiology and Management of the Newborn. Philadelphia: Lippincott Williams and Wilkins; 1999:765-819.
Porto SO. Jaundice in congenital malrotation of the intestine. Am J Dis Child. 1969 Jun;117(6):684-8. — View Citation
Rosta J, Makói Z, Kertész A. Delayed meconium passage and hyperbilirubinaemia. Lancet. 1968 Nov 23;2(7578):1138. — View Citation
Weisman LE, Merenstein GB, Digirol M, Collins J, Frank G, Hudgins C. The effect of early meconium evacuation on early-onset hyperbilirubinemia. Am J Dis Child. 1983 Jul;137(7):666-8. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Number of Hours of Required Phototherapy | from time of enrollment to time of discharge, for a maximum of 10 weeks | No | |
Secondary | Number of Episodes of Repeat Phototherapy | 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. | from time of enrollment to time of discharge, for a maximum of 10 weeks | No |
Secondary | Peak Total Serum Bilirubin Level | 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. | from time of enrollment to time of discharge every 12 hours while under phototherapy, for a maximum of 10 weeks | No |
Secondary | Rate of Decline in Bilirubin Levels (mg/dL/hr) | Absolute change over time from peak to first discontinuation of phototherapy lights | from time of enrollment to time of discharge, for a maximum of 10 weeks | No |
Secondary | Length of Initial Round of Phototherapy | time start to time finally off phototherapy, including any breaks during which they were off | from time of enrollment to time of discharge, for a maximum of 10 weeks | No |
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