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OpenTrials
Completed

NCT Number: NCT02221167

Rx Milk Study of Donor Milk Supplementation to Improve Breastfeeding Outcomes

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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Key information

Age range

24 hour–48 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa Children's Hospital

Iowa City, Iowa, 52242, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

donor milk

Other

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

Primary outcomes

  1. Any formula use at 1 week of age

    Time frame: 1 week

    Any formula intake within the last 24 hours.

Secondary outcomes

  1. Exclusive breastfeeding

    Time frame: 3 months

    Infants receiving breast milk and no formula in the last 24 hours.

  2. 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. Any breastfeeding

    Time frame: 1 month

  4. Exclusive breastfeeding

    Time frame: 1 month

  5. Exclusive breastfeeding

    Time frame: 2 months

  6. Any breastfeeding

    Time frame: 2 months

  7. Any breastfeeding

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

Laura Kair

Other

Collaborators

  • Children's Miracle Network
  • The Gerber Foundation

Registry information

Official study title

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

Acronym: Rx Milk

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 20, 2014
Registry last updated
Mar 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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