Effect of Early Limited Formula on Total Serum Bilirubin Among Newborns With Hyperbilirubinemia

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01330667
First received: February 23, 2011
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

The investigators propose to conduct an exploratory pilot study, enrolling 30 exclusively breastfeeding newborns 36-96 hours of age, whose Total Serum Bilirubin (TSB) is within 0.1-3 mg/dl of the American Academy of Pediatrics (AAP)-recommended treatment thresholds for Phototherapy (PT). These newborns will be randomly assigned to receive either 10 cc extensively hydrolyzed formula following each breastfeeding using cup, spoon or syringe, or to continue exclusive breastfeeding. Infants will be followed at 1, 2, 3 and 6 months to assess breastfeeding duration and use of formula and complementary foods. Our hypothesis is that limited, small amounts of formula administered without a bottle immediately following breastfeeding might reduce the incidence of severe hyperbilirubinemia among newborns at increased risk of TSB exceeding AAP-recommended thresholds for beginning phototherapy.


Condition Intervention
Hyperbilirubinemia, Neonatal
Dietary Supplement: Nutramigen Infant Formula

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Early Limited Formula on Total Serum Bilirubin Among Newborns With Hyperbilirubinemia

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • TSB meeting or exceeding AAP-recommended phototherapy treatment threshold. [ Time Frame: Up to two weeks after birth ] [ Designated as safety issue: No ]
    The investigators will compare measured TSB to AAP guideline recommendations for phototherapy treatment and confirming with Bili Tool, an automated program designed for this purpose.


Secondary Outcome Measures:
  • Receipt of phototherapy and hospital readmission, exclusive and partial breastfeeding at 1 week, 1 month, 2 months, and 3 months; breastfeeding self-efficacy [ Time Frame: Up to three months after birth ] [ Designated as safety issue: No ]
    The investigators will ask mothers whether the infant received any breast milk in the last 24 hours. For infants whose mothers state they have received breast milk in the last 24 hours, the investigators will ask mothers whether the infant received anything other than breast milk in the last 24 hours. The investigators will ask mothers whether the infant received anything other than breast milk since the prior assessment. The investigators will query subjects using the Breastfeeding Self Efficacy Scale, short form, at enrollment, 1week and at 1 month.


Estimated Enrollment: 30
Study Start Date: December 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Formula Supplementation
Participants will supplement feedings with early limited formula following nursing.
Dietary Supplement: Nutramigen Infant Formula
Investigators will advise to supplement with 10cc's of extensively hydrolyzed formula immediately following each breastfeeding until TSB declines.
Other Name: Nutramigen
No Intervention: Control
Participants will be instructed to continue exclusively breastfeeding with no formula supplementation.

Detailed Description:

Inclusion criteria

  • Healthy infants ≥ 35 weeks
  • Neonates 36-96 hours old
  • Exclusively breastfeeding
  • TSB 0.1-3 mg/dl below AAP-recommended PT threshold
  • TSB < 6 hours ago
  • Mothers English-speaking or Spanish-speaking

Outcome Measures

  • Primary outcome: Total Serum Bilirubin
  • Secondary clinical outcomes: Phototherapy, hospital readmission, exclusive and partial breastfeeding at 1 week, 1 month, 2 months, and 3 months; breastfeeding self-efficacy
  Eligibility

Ages Eligible for Study:   up to 96 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy infants ≥ 35 weeks
  • Neonates 36-96 hours old
  • Exclusively breastfeeding
  • TSB 0.1-3 mg/dl below AAP-recommended PT threshold
  • TSB < 6 hours ago
  • Mothers English-speaking or Spanish-speaking

Exclusion Criteria:

  • Infants who have already received formula
  • Infants who have received or are receiving Level II or Level III
  • Infants who have already lost ≥ 10% birth weight
  • Infants with Glucose-6-phosphate dehydrogenase deficiency, positive direct antigen testing, cephalohematoma or other extensive bruising
  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: NCT01330667

Contacts
Contact: Helen Ashton 415-476-2859

Locations
United States, California
University of California, San Francisco Medical Center Not yet recruiting
San Francisco, California, United States, 94122
Principal Investigator: Valerie Flaherman, MD,MPH         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Valerie Flaherman, MD,MPH University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01330667     History of Changes
Other Study ID Numbers: ELF for Hyperbilirubinemia
Study First Received: February 23, 2011
Last Updated: May 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Hyperbilirubinemia
Breastfeeding
Limited Formula

Additional relevant MeSH terms:
Hyperbilirubinemia
Hyperbilirubinemia, Neonatal
Infant, Newborn, Diseases
Pathologic Processes
Bilirubin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on October 22, 2014