Rx Milk Study of Donor Milk Supplementation to Improve Breastfeeding Outcomes

Exclusive Breastfeeding Clinical Trial

— Rx Milk  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02221167
• Other study ID #: 201406730
• Status: Completed
• Phase: N/A
• First received: August 18, 2014
• Last updated: March 14, 2018
• Start date: July 2014
• Est. completion date: September 2016

Study information

• Verified date: March 2018
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 48 Hours

Eligibility

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%

Related Conditions & MeSH terms

• Breastfeeding Duration
• Donor Milk Supplementation
• Exclusive Breastfeeding

Intervention

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

Locations

Country	Name	City	State
United States	University of Iowa Children's Hospital	Iowa City	Iowa

Sponsors (3)

Lead Sponsor	Collaborator
Laura Kair	Children's Miracle Network, The Gerber Foundation

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any formula use at 1 week of age	Any formula intake within the last 24 hours.	1 week
Secondary	Exclusive breastfeeding	Infants receiving breast milk and no formula in the last 24 hours.	3 months
Secondary	Any breastfeeding at 3 months	Infants receiving some breast milk in addition to some formula in the last 24 hours.	3 months
Secondary	Any breastfeeding		1 month
Secondary	Exclusive breastfeeding		1 month
Secondary	Exclusive breastfeeding		2 months
Secondary	Any breastfeeding		2 months
Secondary	Any breastfeeding		1 week

External Links

•   Baby Friendly USA
•   Joint Commission Perinatal Core Measures