Rx Milk Study of Donor Milk Supplementation to Improve Breastfeeding Outcomes

Overview

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.

Full Title of Study: “Rx Milk: Donor Milk Supplementation to Increase Breastfeeding Duration & Exclusivity, a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2016

Interventions

  • Other: Donor Milk
    • breastfeeding plus 10 ml of donor milk by syringe after each breastfeeding until mother’s milk “comes in.”

Arms, Groups and Cohorts

  • 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)

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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%

Gender Eligibility: All

Minimum Age: 24 Hours

Maximum Age: 48 Hours

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Laura Kair
  • Collaborator
    • Children’s Miracle Network
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Laura Kair, Adjunct Assistant Professor – University of Iowa
  • Overall Official(s)
    • Laura R Kair, MD, Principal Investigator, University of Iowa
    • Tarah T Colaizy, MD, MPH, Study Director, University of Iowa
    • Valerie J Flaherman, MD, MPH, Study Director, University of California, San Francisco

References

Flaherman VJ, Aby J, Burgos AE, Lee KA, Cabana MD, Newman TB. Effect of early limited formula on duration and exclusivity of breastfeeding in at-risk infants: an RCT. Pediatrics. 2013 Jun;131(6):1059-65. doi: 10.1542/peds.2012-2809. Epub 2013 May 13.

Flaherman VJ, Kuzniewicz MW, Li S, Walsh E, McCulloch CE, Newman TB. First-day weight loss predicts eventual weight nadir for breastfeeding newborns. Arch Dis Child Fetal Neonatal Ed. 2013 Nov;98(6):F488-92. doi: 10.1136/archdischild-2012-303076. Epub 2013 Jul 17.

Flaherman VJ, Bokser S, Newman TB. First-day newborn weight loss predicts in-hospital weight nadir for breastfeeding infants. Breastfeed Med. 2010 Aug;5(4):165-8. doi: 10.1089/bfm.2009.0047.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.