Rx Milk Study of Donor Milk Supplementation to Improve Breastfeeding Outcomes (Rx Milk)

March 14, 2018 updated by: Laura Kair

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Exclusive breastfeeding
Infants in the exclusive breastfeeding group will continue to breastfeed.
Active Comparator: 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)
Other: Donor Milk
breastfeeding plus 10 ml of donor milk by syringe after each breastfeeding until mother's milk "comes in."
Other Names:
  • donor breast milk
  • human donor milk

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laura Kair

Collaborators

The Gerber Foundation
Children's Miracle Network

Investigators

  • Principal Investigator: Laura R Kair, MD, University of Iowa
  • Study Director: Tarah T Colaizy, MD, MPH, University of Iowa
  • Study Director: Valerie J Flaherman, MD, MPH, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

August 18, 2014

First Submitted That Met QC Criteria

August 19, 2014

First Posted (Estimate)

August 20, 2014

Study Record Updates

Last Update Posted (Actual)

March 16, 2018

Last Update Submitted That Met QC Criteria

March 14, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 201406730

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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