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

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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.


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%
We found this trial at
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Iowa City, IA
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