Effect of Early Limited Formula Use on Breastfeeding Outcomes (ELF)

April 9, 2014 updated by: University of California, San Francisco
The aim of this study is to conduct a pilot randomized controlled trial of the effect of early limited formula supplementation on breastfeeding-related outcomes for infants with high early weight loss. The investigators will enroll 40 exclusively breastfeeding infants at 24-48 hours of age and will randomly assign them to early limited formula supplementation following nursing (intervention group) or to no formula feeding (control group). Both groups will receive intensive lactation support. Outcome variables will include breastfeeding status on day-of-life 8, weight nadir, breastfeeding self-efficacy, maternal satisfaction, and exclusive and partial breastfeeding at 1-3 months. The hypothesis for this study is that early limited formula supplementation might help infants with early weight loss avoid eventual weight loss ≥ 10% and associated breastfeeding problems.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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, 94143
        • 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 2 days (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy term infants (37 to 42 weeks gestation)
  • Infants who have lost 5% of their birth weight at <36 hours of age

Exclusion Criteria:

  • Infants who have received formula or water
  • Mothers who are producing mature milk supply
  • Infants receiving Level II or Level III care other than healthy term infants with routine complete blood count and blood tests pending

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Limited Formula
Participants will supplement feedings with early limited formula following nursing
Dietary supplement: Nutramigen infant formula
Investigators will advise mothers to supplement with 10 cc of elemental formula immediately following each breastfeeding and to discontinue formula once mature milk production begins.
No Intervention: Control
Participants are instructed to continue exclusively breastfeeding; no use of formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Is infant receiving exclusively breast milk at 8 days of life?
Time Frame: 8 days following baseline
8 days following baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Is infant receiving exclusive or partial breastfeeding at 1 month, 2 months, and 3 months?
Time Frame: 1-3 months following baseline
1-3 months following baseline

Collaborators and Investigators

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

Sponsor

University of California, San Francisco

Collaborators

Stanford University

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

August 1, 2009

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

July 29, 2009

First Submitted That Met QC Criteria

August 3, 2009

First Posted (Estimate)

August 6, 2009

Study Record Updates

Last Update Posted (Estimate)

April 10, 2014

Last Update Submitted That Met QC Criteria

April 9, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H49316-34032-01
  • 5 K12 HD052 163 Development

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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