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Human Milk

Bottle Supplementation--Commercially-Sterilized Donor Human Milk for Neonatal Hypoglycemia

N/A
Waitlist Available
Led By Melissa K Thoene, RD, PhD
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Mother-infant pairs will be consented for participation via informed written consent.
Mother/infant dyads deliverying at Nebraska Medicine hospital (Omaha, NE, USA).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up families of consented participants will be contacted when the enrolled infant is 6 months old.
Awards & highlights

Study Summary

This trial will see if supplementing with donor milk can help improve hypoglycemia in exclusively breastfed infants.

Eligible Conditions
  • Neonatal Hypoglycemia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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A mother and her infant must both agree in writing to participate.
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You gave birth at Nebraska Medicine hospital in Omaha, NE, USA and you are with your baby.
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Your baby is a full-term newborn (at least 36 weeks gestational age) in the regular nursery.
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Newborns with very low blood sugar levels (less than 40 mg/dL in the first 4 hours or less than 45 mg/dL after 4 hours) will not be included in the study.
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You plan to only feed your baby breast milk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~families of consented participants will be contacted when the enrolled infant is 6 months old.
This trial's timeline: 3 weeks for screening, Varies for treatment, and families of consented participants will be contacted when the enrolled infant is 6 months old. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effectiveness of Resolving Neonatal Hypoglycemia: Blood glucose levels
Secondary outcome measures
Exclusive Breastfeeding Duration
Parenteral Satisfaction of Infant Feeding: Parenteral satisfaction surveys

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Commercially-Sterilized Donor Human MilkExperimental Treatment1 Intervention
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 II: Standard Infant FormulaActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bottle Supplementation--Commercially-Sterilized Donor Human Milk
2020
N/A
~20

Find a Location

Who is running the clinical trial?

Nebraska MedicineUNKNOWN
University of NebraskaLead Sponsor
533 Previous Clinical Trials
1,143,853 Total Patients Enrolled
Melissa K Thoene, RD, PhDPrincipal InvestigatorNebraska Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who qualifies to partake in this experimental venture?

"This research endeavour is seeking 62 individuals suffering from hypoglycemia aged 1 Minute to 72 Hours. Eligibility criteria necessitate that patients meet the following conditions: possess a blood sugar level of less than 40 milligrams/deciliter within four hours post-birth or inferior to 45 milligrams/deciliter after 4 hours, be accompanied by their mother (who must provide written consent), give birth at Nebraska Medicine hospital in Omaha, have been gestationally developed for more than 36 weeks and plan on breastfeeding exclusively."

Answered by AI

Is there still capacity for volunteers to join this clinical research?

"The details listed on clinicaltrials.gov suggest that this research trial is no longer actively enrolling participants; however, there are 86 other trials looking for volunteers currently active in the same area of medicine. This study was first posted to the website on May 1st 2020 and its last update was recorded November 9th 2022."

Answered by AI

Does this clinical trial include senior citizens aged eighty-five or above?

"Based on the trial's eligibility requirements, the minimum age of admission is 1 Minute and the upper limit of acceptance is 72 Hours."

Answered by AI
~4 spots leftby Mar 2025