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

University of Nebraska

Status: Completed

Conditions: Neonatal Hypoglycemia

Treatments: Dietary Supplement: Bottle Supplementation--Standard Infant Formula; Dietary Supplement: Bottle Supplementation--Commercially-Sterilized Donor Human Milk

Study type: Interventional

Funder types: Other

Identifiers

NCT04030312

0119-19-EP

Details and patient eligibility

About

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.

Full 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).

Enrollment: 18 patients

Sex: All

Ages: 1 minute to 72 hours old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Standard Infant Formula

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Bottle Supplementation--Standard Infant Formula

Commercially-Sterilized Donor Human Milk

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Bottle Supplementation--Commercially-Sterilized Donor Human Milk