Glycerin Suppositories to Reduce Jaundice in Premature Infants

NCT01746511 | Completed Results

• 1 other identifier: RSRB00040723
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Idiopathic Hyperbilirubinemia; Neonatal Hyperbilirubinemia; Prematurity

Keywords

glycerin suppositories; glycerin shaves; neonatal hyperbilirubinemia; idiopathic hyperbilirubinemia; jaundice; neonatal jaundice; prematurity

Outcome Measures

Primary Outcomes (1)

• Total Number of Hours of Required Phototherapy

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

Secondary Outcomes (4)

• Number of Episodes of Repeat Phototherapy

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

• 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

• Rate of Decline in Bilirubin Levels (mg/dL/hr)

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

• Length of Initial Round of Phototherapy

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

Study Arms (2)

Glycerin Suppository

ACTIVE COMPARATOR

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.

Procedure: Phototherapy; Drug: glycerin suppository

No Glycerin Suppository

EXPERIMENTAL

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.

Procedure: Phototherapy

Interventions

Phototherapy PROCEDURE

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.

Also known as: Bili light

Glycerin Suppository; No Glycerin Suppository

glycerin suppository DRUG

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 standard dose of glycerin suppository which is 0.25 of the pediatric suppository or 0.3 grams.

Also known as: glycerin shave

Glycerin Suppository

Eligibility Criteria

• Age: 30 Weeks - 35 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center NICU

Rochester, New York, 14642, United States

Location

Related Publications (11)

• 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.

  BACKGROUND

• Rosta J, Makoi Z, Kertesz A. Delayed meconium passage and hyperbilirubinaemia. Lancet. 1968 Nov 23;2(7578):1138. doi: 10.1016/s0140-6736(68)91603-6. No abstract available.

  PMID: 4177180 BACKGROUND

• Porto SO. Jaundice in congenital malrotation of the intestine. Am J Dis Child. 1969 Jun;117(6):684-8. doi: 10.1001/archpedi.1969.02100030686011. No abstract available.

  PMID: 5771508 BACKGROUND

• Jirsova V, Janovsky M. Hyperbilirubinemia connected with parenteral administration of higher amounts of fluids in premature infants. Biol Neonate. 1978;33(3-4):132-4. doi: 10.1159/000241062.

  PMID: 98182 BACKGROUND

• 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. doi: 10.1016/s0022-3476(85)80418-2.

  PMID: 4056981 BACKGROUND

• 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.

  PMID: 3646618 BACKGROUND

• 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. doi: 10.1055/s-2005-871529.

  PMID: 16118723 BACKGROUND

• 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. doi: 10.1001/archpedi.1983.02140330050013.

  PMID: 6858980 BACKGROUND

• Chen JY, Ling UP, Chen JH. Early meconium evacuation: effect on neonatal hyperbilirubinemia. Am J Perinatol. 1995 Jul;12(4):232-4. doi: 10.1055/s-2007-994460.

  PMID: 7575822 BACKGROUND

• Amin, S. (2011). Personal communication.

  BACKGROUND

• 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.

  PMID: 19171584 BACKGROUND

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal; Premature Birth; Jaundice; Jaundice, Neonatal

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Carl D'Angio
• Organization: University of Rochester

carol_dangio@urmc.rochester.edu

585-273-4911

Study Officials

• Meggan Butler-O'Hara, RN, MSN, PNP

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics, Neonatology and Medical Humanities; Director, Neonatal Clinical Research; Director, Pediatric Clinical Research Office

Study Record Dates

• First Submitted: October 8, 2012
• First Posted: December 11, 2012
• Study Start: July 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 9, 2015
• Results First Posted: December 9, 2015

Record last verified: 2015-11

Locations

US (1)