MedTrace Logo

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

NCT04030312 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-09-29

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Melissa K Thoene, RD, PhD · Nebraska Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
72 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2022-07-01
Completion
2023-04-10

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04030312 on ClinicalTrials.gov