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Effectiveness of Donor Human Milk Supplementation for the Treatment of Hypoglycemia in the Breastfed Infant

Neonatal Hypoglycemia Clinical Trial

Official title:
Effectiveness of Donor Human Milk Supplementation Compared to Infant Formula for the Treatment of Hypoglycemia in the Breastfed Infant in the Normal Newborn Nursery

Clinical Trial 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. Hypothesis is that supplementation with commercially-sterilized donor human milk will improve hypoglycemia and limit formula use in exclusively breastfed infants.

Clinical Trial 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 OR 20-calorie-per-ounce standard infant formula) as treatment if they meet hypoglycemia criteria. Infant participants will complete the study if 1) they have received two bottle feeding supplementations for treatment of hypoglycemia, 2) they only received one bottle supplementation and hypoglycemia resolved, 3) if the medical teams deems the infants requires a higher level of care for their hypoglycemia (example: admission to the newborn intensive care unit for intravenous fluids with dextrose). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04030312
Study type Interventional
Source University of Nebraska
Contact
Status Completed
Phase N/A
Start date May 1, 2020
Completion date April 10, 2023
View Details
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