Rx Milk Study of Donor Milk Supplementation to Improve Breastfeeding Outcomes

Study Overview
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Brief Summary
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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.

Official Title
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Rx Milk: Donor Milk Supplementation to Increase Breastfeeding Duration & Exclusivity, a Randomized Controlled Trial

Conditions
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Breastfeeding Duration, Exclusive Breastfeeding, Donor Milk Supplementation

Intervention / Treatment
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* Other: Donor Milk


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 24 Hours
Maximum Age: 48 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Exclusive breastfeeding<br>Infants in the exclusive breastfeeding group will continue to breastfeed. | |
| Active Comparator: Donor Milk<br>Infants in this arm will continue to breastfeed and will be given 10 ml of donor breast milk by syringe after each breastfeeding until their mother's milk comes in. (until the onset of lactogenesis II) | Other: Donor Milk<br>* breastfeeding plus 10 ml of donor milk by syringe after each breastfeeding until mother's milk comes in.<br>* Other names: human donor milk;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any formula use at 1 week of age | Any formula intake within the last 24 hours. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exclusive breastfeeding | Infants receiving breast milk and no formula in the last 24 hours. | 3 months | 
| Any breastfeeding at 3 months | Infants receiving some breast milk in addition to some formula in the last 24 hours. | 3 months | 
| Any breastfeeding |  | 1 month | 
| Exclusive breastfeeding |  | 1 month | 
| Exclusive breastfeeding |  | 2 months | 
| Any breastfeeding |  | 2 months | 
| Any breastfeeding |  | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breastfeeding, donor milk, formula, exclusive breastfeeding, newborn