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

Sponsor

University of Nebraska (Other)

Overall Status

Recruiting

CT.gov ID

NCT04030312

Collaborator

Nebraska Medicine (Other)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neonatal Hypoglycemia	Dietary Supplement: Bottle Supplementation--Commercially-Sterilized Donor Human Milk Dietary Supplement: Bottle Supplementation--Standard Infant Formula	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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.
Experimental: 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.	Dietary Supplement: 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.

Arm

Intervention/Treatment

Active Comparator: 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.

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.

Experimental: 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.

Dietary Supplement: 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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Minute to 72 Hours

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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