This study is a randomized controlled trial seeking to determine whether supplementing infants at risk for excessive neonatal weight loss with a small volume of human donor milk prophylactically in the first 1-3 days of life, before maternal mature milk production (before mom's milk "comes in") will decrease the incidence of formula use at 1 week and 1, 2, and 3 months of life and increase the rate of exclusive breastfeeding in this high-risk population. We hypothesize that supplementation of term infants who have lost greater than or equal to 5% birth weight by 36 hours of age with a small volume of donor breast milk following feeds, until mature milk production, will result in decreased supplemental formula use at 1 week and increased exclusive as well as any breastfeeding at 1 week and 1, 2, and 3 months. This study's specific aims are to compare the effectiveness of encouraging in-hospital exclusive breastfeeding with offering early small-volume donor milk supplementation in a population of infants at risk for excessive neonatal weight loss with goals of 1) decreasing the incidence of formula supplementation at 1 week of life and 2) improving breastfeeding duration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
breastfeeding plus 10 ml of donor milk by syringe after each breastfeeding until mother's milk "comes in."
University of Iowa Children's Hospital
Iowa City, Iowa, United States
Any formula use at 1 week of age
Any formula intake within the last 24 hours.
Time frame: 1 week
Exclusive breastfeeding
Infants receiving breast milk and no formula in the last 24 hours.
Time frame: 3 months
Any breastfeeding at 3 months
Infants receiving some breast milk in addition to some formula in the last 24 hours.
Time frame: 3 months
Any breastfeeding
Time frame: 1 month
Exclusive breastfeeding
Time frame: 1 month
Exclusive breastfeeding
Time frame: 2 months
Any breastfeeding
Time frame: 2 months
Any breastfeeding
Time frame: 1 week
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