Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Glycerin Suppositories to Reduce Jaundice in Premature Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carl D'Angio, University of Rochester
ClinicalTrials.gov Identifier:
NCT01746511
First received: October 8, 2012
Last updated: November 4, 2015
Last verified: November 2015
  Purpose

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.


Condition Intervention
Idiopathic Hyperbilirubinemia
Neonatal Hyperbilirubinemia
Prematurity
Procedure: Phototherapy
Drug: glycerin suppository

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Glycerin Suppositories to Reduce Hyperbilirubinemia in Premature Infants Requiring Phototherapy

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Total Number of Hours of Required Phototherapy [ Time Frame: from time of enrollment to time of discharge, for a maximum of 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Episodes of Repeat Phototherapy [ Time Frame: from time of enrollment to time of discharge, for a maximum of 10 weeks ] [ Designated as safety issue: No ]
    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.

  • Peak Total Serum Bilirubin Level [ Time Frame: from time of enrollment to time of discharge every 12 hours while under phototherapy, for a maximum of 10 weeks ] [ Designated as safety issue: No ]
    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.

  • Rate of Decline in Bilirubin Levels (mg/dL/hr) [ Time Frame: from time of enrollment to time of discharge, for a maximum of 10 weeks ] [ Designated as safety issue: No ]
    Absolute change over time from peak to first discontinuation of phototherapy lights

  • Length of Initial Round of Phototherapy [ Time Frame: from time of enrollment to time of discharge, for a maximum of 10 weeks ] [ Designated as safety issue: No ]
    time start to time finally off phototherapy, including any breaks during which they were off


Enrollment: 79
Study Start Date: July 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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:

  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
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.
Other Name: Bili light
Drug: glycerin suppository
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.
Other Name: glycerin shave
Experimental: No Glycerin Suppository

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
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.
Other Name: Bili light

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Weeks to 35 Weeks   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746511

Locations
United States, New York
University of Rochester Medical Center NICU
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Meggan Butler-O'Hara, RN, MSN, PNP University of Rochester
  More Information

Publications:
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.
Amin, S. (2011). Personal communication.

Responsible Party: Carl D'Angio, Associate Professor of Pediatrics, Neonatology and Medical Humanities; Director, Neonatal Clinical Research; Director, Pediatric Clinical Research Office, University of Rochester
ClinicalTrials.gov Identifier: NCT01746511     History of Changes
Other Study ID Numbers: RSRB00040723 
Study First Received: October 8, 2012
Results First Received: September 16, 2015
Last Updated: November 4, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
glycerin suppositories
glycerin shaves
neonatal hyperbilirubinemia
idiopathic hyperbilirubinemia
jaundice
neonatal jaundice
prematurity

Additional relevant MeSH terms:
Premature Birth
Hyperbilirubinemia
Jaundice
Hyperbilirubinemia, Neonatal
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Infant, Newborn, Diseases
Glycerol
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 06, 2016