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

This study has been completed.
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00952328
First received: July 29, 2009
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Breastfeeding
Dietary Supplement: Nutramigen infant formula

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Early Limited Formula Use on Breastfeeding Outcomes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Is infant receiving exclusively breast milk at 8 days of life? [ Time Frame: 8 days following baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Is infant receiving exclusive or partial breastfeeding at 1 month, 2 months, and 3 months? [ Time Frame: 1-3 months following baseline ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: August 2009
Study Completion Date: April 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 48 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00952328

Locations
United States, California
University of California, San Francisco Medical Center
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Stanford University
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: NCT00952328     History of Changes
Other Study ID Numbers: H49316-34032-01, 5 K12 HD052 163 Development
Study First Received: July 29, 2009
Last Updated: April 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
breastfeeding outcomes
breastfeeding self-efficacy
infant weight loss

ClinicalTrials.gov processed this record on October 23, 2014