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

NCT04030312 | Completed DMC

• 1 other identifier: 0119-19-EP
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Hypoglycemia

Keywords

neonatal; newborn; hypoglycemia; human milk; breastfed; donor milk

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Exclusive Breastfeeding Duration

  Families of consented participants will be contacted when the enrolled infant is 6 months old.

• 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).

Study Arms (2)

Standard Infant Formula

ACTIVE COMPARATOR

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.

Dietary Supplement: Bottle Supplementation--Standard Infant Formula

Commercially-Sterilized Donor Human Milk

EXPERIMENTAL

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.

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

Interventions

Bottle Supplementation--Commercially-Sterilized Donor Human Milk 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.

Commercially-Sterilized Donor Human Milk

Bottle Supplementation--Standard Infant Formula 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.

Standard Infant Formula

Eligibility Criteria

• Age: 1 Minute - 72 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Hypoglycemia; Breast Feeding

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Feeding Behavior; Behavior

Study Officials

• Melissa K Thoene, RD, PhD

  Nebraska Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: July 23, 2019
• Study Start: May 1, 2020
• Primary Completion: July 1, 2022
• Study Completion: April 10, 2023
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)