Rx Milk Study of Donor Milk Supplementation to Improve Breastfeeding Outcomes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-09-30

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.

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Detailed Description

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Conditions

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Breastfeeding Duration Exclusive Breastfeeding Donor Milk Supplementation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Exclusive breastfeeding

Infants in the exclusive breastfeeding group will continue to breastfeed.

Group Type NO_INTERVENTION

No interventions assigned to this group

Donor Milk

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)

Group Type ACTIVE_COMPARATOR

Donor Milk

Intervention Type OTHER

breastfeeding plus 10 ml of donor milk by syringe after each breastfeeding until mother's milk "comes in."

Interventions

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Donor Milk

breastfeeding plus 10 ml of donor milk by syringe after each breastfeeding until mother's milk "comes in."

Intervention Type OTHER

Other Intervention Names

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donor breast milk human donor milk

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%

Minimum Eligible Age

24 Hours

Maximum Eligible Age

48 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No