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NCT04030312 · ClinicalTrials.gov registry record · NA
Effectiveness of Donor Human Milk Supplementation for the Treatment of Hypoglycemia in the Breastfed Infant
A NA study of Neonatal Hypoglycemia, sponsored by University of Nebraska.
- Completed
- Registry status
- NA
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT04030312: Completed NA study of Neonatal Hypoglycemia, sponsored by University of Nebraska.
NCT04030312 is a NA study of Neonatal Hypoglycemia that has completed, run by University of Nebraska. The registered enrollment target is 18 participants, below the 139-participant average among 5 other Neonatal Hypoglycemia trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04030312, a NA study of Neonatal Hypoglycemia, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Bottle Supplementation--Commercially-Sterilized Donor Human Milk
- DIETARY_SUPPLEMENT Bottle Supplementation--Standard Infant Formula
Study Locations (1)
Nebraska
- University of Nebraska Medical Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2020-05-01 |
| Est. Completion | 2023-04-10 |
| Phase | NA |
What the finished NCT04030312 record still lists
NCT04030312 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 139-participant average among 5 other Neonatal Hypoglycemia trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Neonatal Hypoglycemia appearing as the primary indexed condition, and to 2 interventions - of which Bottle Supplementation--Commercially-Sterilized Donor Human Milk is the first listed.
NCT04030312 reports a single indexed study location in Nebraska.
Frequently Asked Questions
What is clinical trial NCT04030312 about?
NCT04030312 is a clinical study titled "Effectiveness of Donor Human Milk Supplementation for the Treatment of Hypoglycemia in the Breastfed Infant". 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 hypoglycem...
What is the current status of trial NCT04030312?
This trial is currently completed. It is a NA study. The enrollment target is 18 participants. The study started on 2020-05-01. Estimated completion is 2023-04-10.
What conditions does trial NCT04030312 study?
This clinical trial studies the following conditions: Neonatal Hypoglycemia.
What interventions are being tested in trial NCT04030312?
The interventions under investigation include: Bottle Supplementation--Commercially-Sterilized Donor Human Milk (DIETARY_SUPPLEMENT), Bottle Supplementation--Standard Infant Formula (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04030312?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04030312 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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