Rx Milk Study of Donor Milk Supplementation to Improve Breastfeeding Outcomes (Rx Milk)
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|ClinicalTrials.gov Identifier: NCT02221167|
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : March 16, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Breastfeeding Duration Exclusive Breastfeeding Donor Milk Supplementation||Other: Donor Milk||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rx Milk: Donor Milk Supplementation to Increase Breastfeeding Duration & Exclusivity, a Randomized Controlled Trial|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||September 2016|
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)
Other: Donor Milk
breastfeeding plus 10 ml of donor milk by syringe after each breastfeeding until mother's milk "comes in."
- Any formula use at 1 week of age [ Time Frame: 1 week ]Any formula intake within the last 24 hours.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221167
|United States, Iowa|
|University of Iowa Children's Hospital|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Laura R Kair, MD||University of Iowa|
|Study Director:||Tarah T Colaizy, MD, MPH||University of Iowa|
|Study Director:||Valerie J Flaherman, MD, MPH||University of California, San Francisco|