Rx Milk Study of Donor Milk Supplementation to Improve Breastfeeding Outcomes

NCT02221167 | Completed

• 1 other identifier: 201406730
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding Duration; Exclusive Breastfeeding; Donor Milk Supplementation

Keywords

breastfeeding; donor milk; formula; exclusive breastfeeding; newborn

Outcome Measures

Primary Outcomes (1)

• Any formula use at 1 week of age

  Any formula intake within the last 24 hours.

  1 week

Secondary Outcomes (7)

• Exclusive breastfeeding

  3 months

• Any breastfeeding at 3 months

  3 months

• Any breastfeeding

  1 month

• Exclusive breastfeeding

  1 month

• Exclusive breastfeeding

  2 months

Study Arms (2)

Exclusive breastfeeding

NO INTERVENTION

Infants in the exclusive breastfeeding group will continue to breastfeed.

Donor Milk

ACTIVE COMPARATOR

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

Interventions

Donor Milk OTHER

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

Also known as: donor breast milk, human donor milk

Donor Milk

Eligibility Criteria

• Age: 24 Hours - 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• Laura Kair: lead
• Children's Miracle Network: collaborator
• The Gerber Foundation: collaborator

Study Sites (1)

University of Iowa Children's Hospital

Iowa City, Iowa, 52242, United States

Location

Related Publications (4)

• 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.

  PMID: 23669513 BACKGROUND

• 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.

  PMID: 23864443 BACKGROUND

• 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.

  PMID: 20113202 BACKGROUND

• Kair LR, Flaherman VJ, Colaizy TT. Effect of Donor Milk Supplementation on Breastfeeding Outcomes in Term Newborns: A Randomized Controlled Trial. Clin Pediatr (Phila). 2019 May;58(5):534-540. doi: 10.1177/0009922819826105. Epub 2019 Jan 28.

  PMID: 30688082 DERIVED

Related Links

• Baby Friendly USA

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Laura R Kair, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Tarah T Colaizy, MD, MPH

  University of Iowa

  STUDY DIRECTOR

• Valerie J Flaherman, MD, MPH

  University of California, San Francisco

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Adjunct Assistant Professor

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: August 20, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: March 16, 2018

Record last verified: 2018-03

Locations

US (1)