Effect of Early Limited Formula Use on Breastfeeding Outcomes

Completed · Not applicable

Conditions studied: Breastfeeding

In brief

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.

Key facts

Study ID

NCT00952328

Run by

University of California, San Francisco

People needed

40

Starts

2009-08-01

Expected to finish

2013-04-01

Last updated by the study team

2014-04-10

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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