University of Iowa Children's Hospital
Iowa City, Iowa, 52242, United States
NCT Number: NCT02221167
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.
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Notify Me24 hour–48 hour
All sexes
Interventional
Not applicable
Iowa City, Iowa, 52242, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
breastfeeding plus 10 ml of donor milk by syringe after each breastfeeding until mother's milk "comes in."
Other names: donor breast milk, human donor milk
Time frame: 1 week
Any formula intake within the last 24 hours.
Time frame: 3 months
Infants receiving breast milk and no formula in the last 24 hours.
Time frame: 3 months
Infants receiving some breast milk in addition to some formula in the last 24 hours.
Time frame: 1 month
Time frame: 1 month
Time frame: 2 months
Time frame: 2 months
Time frame: 1 week
Laura Kair
Other
Rx Milk: Donor Milk Supplementation to Increase Breastfeeding Duration & Exclusivity, a Randomized Controlled Trial
Acronym: Rx Milk
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