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
NCT number | NCT04030312 |
Other study ID # | 0119-19-EP |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2020 |
Est. completion date | April 10, 2023 |
Verified date | September 2023 |
Source | University of Nebraska |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | April 10, 2023 |
Est. primary completion date | July 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Minute to 72 Hours |
Eligibility | Mother-infant pairs will be consented for participation via informed written consent. Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Nebraska Medical Center | Omaha | Nebraska |
Lead Sponsor | Collaborator |
---|---|
University of Nebraska |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effectiveness of Resolving Neonatal Hypoglycemia: Blood glucose levels | To compare the effectiveness of commercially-sterilized donor human milk bottle supplementation for the treatment of hypoglycemia in the breastfed infant in the normal newborn nursery compared to bottle supplementation with standard infant formula. | Blood glucose levels will be monitored within 60 minutes of initiating a feeding. Overall outcomes for each treatment arm will be compared at the completion of the study for all enrolled participants. | |
Secondary | Exclusive Breastfeeding Duration | To assess if donor human milk supplementation (when compared to formula supplementation) impacts rate of exclusive breastfeeding during the first 6 months of life. | Families of consented participants will be contacted when the enrolled infant is 6 months old. | |
Secondary | Parenteral Satisfaction of Infant Feeding: Parenteral satisfaction surveys | To compare if donor human milk supplementation (when compared to formula supplementation) improves parental satisfaction related to infant feeding during post-partum hospitalization. | Parenteral satisfaction surveys will be completed prior to mother's hospital discharge (within 72 hours following delivery). |
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