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

November 13, 2018 updated by: University of California, San Francisco
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94122
        • University of California, San Francisco Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 days (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Nutramigen
No Intervention: Control
Participants will be instructed to continue exclusively breastfeeding with no formula supplementation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TSB meeting or exceeding AAP-recommended phototherapy treatment threshold.
Time Frame: Up to two weeks after birth
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.
Up to two weeks after birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Up to three months after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Valerie Flaherman, MD,MPH, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

February 23, 2011

First Submitted That Met QC Criteria

April 6, 2011

First Posted (Estimate)

April 7, 2011

Study Record Updates

Last Update Posted (Actual)

November 15, 2018

Last Update Submitted That Met QC Criteria

November 13, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELF for Hyperbilirubinemia

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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