Status:
COMPLETED
Effectiveness of Donor Human Milk Supplementation for the Treatment of Hypoglycemia in the Breastfed Infant
Lead Sponsor:
University of Nebraska
Conditions:
Neonatal Hypoglycemia
Eligibility:
All Genders
1-72 years
Phase:
NA
Brief Summary
The purpose of this study is to compare if newborn infant hypoglycemia can be improved with bottle supplementation of commercially-sterilized donor human milk compared to standard infant formula. Hypo...
Detailed Description
Enrolled infant participants will receive a maximum of two bottle feeding supplementations (of their designated treatment arm for either 20 calorie-per-ounce commercially-sterilized donor human milk O...
Eligibility Criteria
Inclusion
- Mother-infant pairs will be consented for participation via informed written consent.
- Mother/infant dyads deliverying at Nebraska Medicine hospital (Omaha, NE, USA).
- Infant in the normal newborn nursery, born greater than or equal to 36 weeks gestational age.
- Infant with blood glucose after delivery of \< 40 milligrams/deciliter within the first four hours of life OR blood glucose levels less than 45 milligrams/deciliter after four hours of life
- Deliverying mother plans to exclusively breastfeed.
Exclusion
- Infants born and directly admitted to the newborn intensive care unit
- Infants with known congenital abnormality or known inborn error of metabolism that influences growth and metabolic outcomes
- Infants deemed ward of state
- Mothers who do not plan to exclusively breastfeed at time of delivery
- Mothers less than 19 years of age
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2023
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04030312
Start Date
May 1 2020
End Date
April 10 2023
Last Update
September 29 2023
Active Locations (1)
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1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198