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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 30 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Nutramigen infant formula
University of California, San Francisco Medical Center
University of California, San Francisco
Published on BioPortfolio: 2014-07-23T16:13:44-0400
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To evaluate the use of a hypoallergenic infant formula containing an extensively hydrolyzed protein source for routine nutrition.
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Liquid formulations for the nutrition of INFANTS, useful for those with special needs or MILK HYPERSENSITIVITY or those whose mothers are unable to breastfeed (BREAST FEEDING).
A human infant born before 37 weeks of GESTATION.
An infant born at or after 42 weeks of gestation.
Any observable response or action of a neonate or infant up through the age of 23 months.
Organized efforts by communities or organizations to improve the health and well-being of the infant.