Rx Milk Study of Donor Milk Supplementation to Improve Breastfeeding Outcomes

Not Applicable

Completed

• Conditions: Breastfeeding Duration; Exclusive Breastfeeding; Donor Milk Supplementation
• Interventions: Other: Donor Milk

• Registration Number: NCT02221167
• Lead Sponsor: Laura Kair

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-18
• Study First Submitted QC: 2014-08-19
• Study First Posted: 2014-08-20
• Primary Completion: 2016-07
• Study Completion: 2016-09
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-14
• Last Update Posted: 2018-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Donor Milk	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)

Primary Outcome Measures

Name	Time	Method
Any formula use at 1 week of age	1 week	Any formula intake within the last 24 hours.

Secondary Outcome Measures

Name	Time	Method
Exclusive breastfeeding	2 months
Any breastfeeding	1 week
Any breastfeeding at 3 months	3 months	Infants receiving some breast milk in addition to some formula in the last 24 hours.

Trial Locations

Locations (1)

University of Iowa Children's Hospital; 🇺🇸 Iowa City, Iowa, United States