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

Not Applicable

Completed

• Conditions: Neonatal Hypoglycemia
• Interventions: Dietary Supplement: Bottle Supplementation--Standard Infant Formula; Dietary Supplement: Bottle Supplementation--Commercially-Sterilized Donor Human Milk

• Registration Number: NCT04030312
• Lead Sponsor: University of Nebraska

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

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 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 Timeline

• Study First Submitted: 2019-04-11
• Study First Submitted QC: 2019-07-22
• Study First Posted: 2019-07-23
• Study Start: 2020-05-01
• Primary Completion: 2022-07-01
• Study Completion: 2023-04-10
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Infant Formula	Bottle Supplementation--Standard Infant Formula	Infants in this randomized treatment arm will receive bottle supplementation of up to 15 milliliters of standard 20 calorie-per-ounce infant formula up to two times during the duration of the study to treat hypoglycemia.
Commercially-Sterilized Donor Human Milk	Bottle Supplementation--Commercially-Sterilized Donor Human Milk	Infants in this randomized treatment arm will receive bottle supplementation of up to 15 milliliters of 20 calorie-per-ounce commercially-sterilized donor human milk up to two times during the duration of the study to treat hypoglycemia.

Primary Outcome Measures

Name	Time	Method
Effectiveness of Resolving Neonatal Hypoglycemia: Blood glucose levels	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.	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.

Secondary Outcome Measures

Name	Time	Method
Exclusive Breastfeeding Duration	Families of consented participants will be contacted when the enrolled infant is 6 months old.	To assess if donor human milk supplementation (when compared to formula supplementation) impacts rate of exclusive breastfeeding during the first 6 months of life.
Parenteral Satisfaction of Infant Feeding: Parenteral satisfaction surveys	Parenteral satisfaction surveys will be completed prior to mother's hospital discharge (within 72 hours following delivery).	To compare if donor human milk supplementation (when compared to formula supplementation) improves parental satisfaction related to infant feeding during post-partum hospitalization.

Trial Locations

Locations (1)

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States