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

Primary Purpose

Neonatal Hypoglycemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bottle Supplementation--Commercially-Sterilized Donor Human Milk
Bottle Supplementation--Standard Infant Formula
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonatal Hypoglycemia focused on measuring neonatal, newborn, hypoglycemia, human milk, breastfed, donor milk

Eligibility Criteria

1 Minute - 72 Hours (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Nebraska Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Infant Formula

Commercially-Sterilized Donor Human Milk

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Exclusive Breastfeeding Duration
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
To compare if donor human milk supplementation (when compared to formula supplementation) improves parental satisfaction related to infant feeding during post-partum hospitalization.

Full Information

First Posted
April 11, 2019
Last Updated
September 27, 2023
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT04030312
Brief Title
Effectiveness of Donor Human Milk Supplementation for the Treatment of Hypoglycemia in the Breastfed Infant
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
April 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Hypoglycemia
Keywords
neonatal, newborn, hypoglycemia, human milk, breastfed, donor milk

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Infant Formula
Arm Type
Active Comparator
Arm 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.
Arm Title
Commercially-Sterilized Donor Human Milk
Arm Type
Experimental
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Bottle Supplementation--Commercially-Sterilized Donor Human Milk
Intervention Description
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
Intervention Name(s)
Bottle Supplementation--Standard Infant Formula
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effectiveness of Resolving Neonatal Hypoglycemia: Blood glucose levels
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Exclusive Breastfeeding Duration
Description
To assess if donor human milk supplementation (when compared to formula supplementation) impacts rate of exclusive breastfeeding during the first 6 months of life.
Time Frame
Families of consented participants will be contacted when the enrolled infant is 6 months old.
Title
Parenteral Satisfaction of Infant Feeding: Parenteral satisfaction surveys
Description
To compare if donor human milk supplementation (when compared to formula supplementation) improves parental satisfaction related to infant feeding during post-partum hospitalization.
Time Frame
Parenteral satisfaction surveys will be completed prior to mother's hospital discharge (within 72 hours following delivery).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
72 Hours
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa K Thoene, RD, PhD
Organizational Affiliation
Nebraska Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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