Glycerin Suppositories to Reduce Jaundice in Premature Infants
Idiopathic Hyperbilirubinemia, Neonatal Hyperbilirubinemia, Prematurity
About this trial
This is an interventional treatment trial for Idiopathic Hyperbilirubinemia focused on measuring glycerin suppositories, glycerin shaves, neonatal hyperbilirubinemia, idiopathic hyperbilirubinemia, jaundice, neonatal jaundice, prematurity
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.
Sites / Locations
- University of Rochester Medical Center NICU
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Glycerin Suppository
No 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: Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs. Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.
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: Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs. Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.