Breastfeeding Duration, Exclusive Breastfeeding, Donor Milk Supplementation
Conditions
Keywords
breastfeeding, donor milk, formula, exclusive breastfeeding, newborn
Brief summary
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.
Interventions
OTHERDonor Milk
breastfeeding plus 10 ml of donor milk by syringe after each breastfeeding until mother's milk comes in.
Sponsors
Children's Miracle Network
The Gerber Foundation
Laura Kair
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
24 Hours to 48 Hours
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Any formula use at 1 week of age | 1 week | Any formula intake within the last 24 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exclusive breastfeeding | 3 months | Infants receiving breast milk and no formula in the last 24 hours. |
| Any breastfeeding at 3 months | 3 months | Infants receiving some breast milk in addition to some formula in the last 24 hours. |
| Any breastfeeding | 1 month | — |
Countries
United States
Outcome results
None listed