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COMPLETED NA

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

NCT04030312 · View on ClinicalTrials.gov ↗

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 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

FieldValue
Enrollment Target 18 participants
Start Date 2020-05-01
Est. Completion 2023-04-10
Phase NA

Sponsor

University of Nebraska

272 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04030312

The ClinicalTrials.gov registry entry for NCT04030312 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Nebraska, which has 272 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04030312 reports 1 study location spanning 1 distinct geographic area — top geographies include Nebraska. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04030312?

This trial is sponsored by University of Nebraska, which has 272 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial