Clinical trial NCT02221167: Rx Milk Study of Donor Milk Supplementation to Improve Breastfeeding Outcomes
Official title: Rx Milk: Donor Milk Supplementation to Increase Breastfeeding Duration & Exclusivity, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding Duration
Exclusive Breastfeeding
Donor Milk Supplementation
Keywords: breastfeeding
donor milk
formula
exclusive breastfeeding
newborn
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Children's Miracle Network
name: The Gerber Foundation
First posted: 2014-08-20
Enrollment: 60
Sex: ALL
Minimum age (years): 24
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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%

Primary outcomes:
measure: Any formula use at 1 week of age
timeFrame: 1 week
Secondary outcomes:
measure: Exclusive breastfeeding
timeFrame: 3 months
measure: Any breastfeeding at 3 months
timeFrame: 3 months
measure: Any breastfeeding
timeFrame: 1 month
measure: Exclusive breastfeeding
timeFrame: 1 month
measure: Exclusive breastfeeding
timeFrame: 2 months
measure: Any breastfeeding
timeFrame: 2 months
measure: Any breastfeeding
timeFrame: 1 week
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Children's Hospital
state: Iowa
Study officials:
affiliation: University of Iowa
name: Laura R Kair, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Tarah T Colaizy, MD, MPH
role: STUDY_DIRECTOR
affiliation: University of California, San Francisco
name: Valerie J Flaherman, MD, MPH
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.