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Clinical Trials/NCT02221167
NCT02221167
Completed
N/A

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

Laura Kair1 site in 1 country60 target enrollmentJuly 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Breastfeeding Duration
Sponsor
Laura Kair
Enrollment
60
Locations
1
Primary Endpoint
Any formula use at 1 week of age
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2014
End Date
September 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Laura Kair
Responsible Party
Sponsor Investigator
Principal Investigator

Laura Kair

Adjunct Assistant Professor

University of Iowa

Eligibility Criteria

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%

Outcomes

Primary Outcomes

Any formula use at 1 week of age

Time Frame: 1 week

Any formula intake within the last 24 hours.

Secondary Outcomes

  • Exclusive breastfeeding(2 months)
  • Any breastfeeding(1 week)
  • Any breastfeeding at 3 months(3 months)

Study Sites (1)

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