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Rx Milk Study of Donor Milk Supplementation to Improve Breastfeeding Outcomes

NCT02221167 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-03-16

No results posted yet for this study

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.

Conditions

  • Breastfeeding Duration
  • Exclusive Breastfeeding
  • Donor Milk Supplementation

Interventions

OTHER

Donor Milk

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

Sponsors & Collaborators

  • Children's Miracle Network

    collaborator OTHER

  • The Gerber Foundation

    collaborator OTHER

  • Laura Kair

    lead OTHER

Principal Investigators

  • Laura R Kair, MD · University of Iowa

  • Tarah T Colaizy, MD, MPH · University of Iowa

  • Valerie J Flaherman, MD, MPH · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
24 Hours
Max Age
48 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-07-31
Completion
2016-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02221167 on ClinicalTrials.gov