Effect of Early Limited Formula Use on Breastfeeding Outcomes

Not Applicable

Completed

• Conditions: Breastfeeding
• Interventions: Dietary Supplement: Nutramigen infant formula

• Registration Number: NCT00952328
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-07-29
• Study Start: 2009-08
• Study First Submitted QC: 2009-08-03
• Study First Posted: 2009-08-06
• Primary Completion: 2012-04
• Study Completion: 2013-04
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-09
• Last Update Posted: 2014-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Limited Formula	Nutramigen infant formula	Participants will supplement feedings with early limited formula following nursing

Primary Outcome Measures

Name	Time	Method
Is infant receiving exclusively breast milk at 8 days of life?	8 days following baseline

Secondary Outcome Measures

Name	Time	Method
Is infant receiving exclusive or partial breastfeeding at 1 month, 2 months, and 3 months?	1-3 months following baseline

Trial Locations

Locations (1)

University of California, San Francisco Medical Center; 🇺🇸 San Francisco, California, United States