Effect of Early Limited Formula Use on Breastfeeding Outcomes

NCT00952328 | Completed

• 2 other identifiers: H49316-34032-015 K12 HD052 163 Development
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breastfeeding

Keywords

breastfeeding outcomes; breastfeeding self-efficacy; infant weight loss

Outcome Measures

Primary Outcomes (1)

• Is infant receiving exclusively breast milk at 8 days of life?

  8 days following baseline

Secondary Outcomes (1)

• Is infant receiving exclusive or partial breastfeeding at 1 month, 2 months, and 3 months?

  1-3 months following baseline

Study Arms (2)

Limited Formula

EXPERIMENTAL

Participants will supplement feedings with early limited formula following nursing

Dietary Supplement: Nutramigen infant formula

Control

NO INTERVENTION

Participants are instructed to continue exclusively breastfeeding; no use of formula

Interventions

Nutramigen infant formula DIETARY_SUPPLEMENT

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.

Limited Formula

Eligibility Criteria

• Age: 24 Hours - 48 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Stanford University: collaborator

Study Sites (1)

University of California, San Francisco Medical Center

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Valerie Flaherman, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2009
• First Posted: August 6, 2009
• Study Start: August 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2013
• Last Updated: April 10, 2014

Record last verified: 2014-04

Locations

US (1)