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

NCT ID: NCT04030312

Last Updated: 2023-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2023-04-10

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).

Conditions

Neonatal Hypoglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Bottle Supplementation--Standard Infant Formula

Intervention Type: DIETARY_SUPPLEMENT

Supplementation by bottle with 20-calorie-per-ounce standard infant formula (up to 15 ml, up to two times) for infants meeting hypoglycemia criteria and randomized to this treatment arm.

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.

Group Type: EXPERIMENTAL

Bottle Supplementation--Commercially-Sterilized Donor Human Milk

Intervention Type: DIETARY_SUPPLEMENT

Supplementation by bottle with 20-calorie-per-ounce commercially-sterilized donor human milk (up to 15 ml, up to two times) for infants meeting hypoglycemia criteria and randomized to this treatment arm.

Interventions

Bottle Supplementation--Commercially-Sterilized Donor Human Milk

Supplementation by bottle with 20-calorie-per-ounce commercially-sterilized donor human milk (up to 15 ml, up to two times) for infants meeting hypoglycemia criteria and randomized to this treatment arm.

Intervention Type: DIETARY_SUPPLEMENT

Bottle Supplementation--Standard Infant Formula

Supplementation by bottle with 20-calorie-per-ounce standard infant formula (up to 15 ml, up to two times) for infants meeting hypoglycemia criteria and randomized to this treatment arm.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 1 Minute
• Maximum Eligible Age: 72 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melissa K Thoene, RD, PhD

Role: PRINCIPAL_INVESTIGATOR

Nebraska Medicine

Locations

University of Nebraska Medical Center

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

0119-19-EP

Identifier Type: -

Identifier Source: org_study_id