Rx Milk Study of Donor Milk Supplementation to Improve Breastfeeding Outcomes
Completed · Not applicable
Conditions studied: Breastfeeding Duration, Exclusive Breastfeeding, Donor Milk Supplementation
In brief
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.
Key facts
- Study ID
- NCT02221167
- Run by
- Laura Kair
- People needed
- 60
- Starts
- 2014-07-01
- Expected to finish
- 2016-09-01
- Last updated by the study team
- 2018-03-16
Who can join
Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Gestational age greater than or equal to 37 weeks
- Weight loss greater than or equal to 5% (rounded to nearest whole percent) of birth weight in the first 36 hours after birth
- Chronologic age of 24-48 hours old at the time of study enrollment
You may not qualify if…
- twins and higher level multiples
- infant has congenital or chromosomal anomalies that may affect feeding, diagnosed prior to study enrollment
- mother incarcerated
- mother's age <18 years
- mother reports mature milk production prior to study enrollment
- mother does not speak English
- infants offered > 1 supplemental feeding of formula or donor milk
- weight loss greater than 10%
Where it is running
- University of Iowa Children's Hospital — Iowa City, Iowa, United States
Full record on ClinicalTrials.gov
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