Effect of Early Limited Formula Use on Breastfeeding Outcomes



Status:Archived
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:August 2009
End Date:September 2011

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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.



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