Rx Milk Study of Donor Milk Supplementation to Improve Breastfeeding Outcomes
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | Any |
Updated: | 4/17/2018 |
Start Date: | July 2014 |
End Date: | September 2016 |
Rx Milk: Donor Milk Supplementation to Increase Breastfeeding Duration & Exclusivity, a Randomized Controlled Trial
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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%
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