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COMPLETED NA

Newborns Supplemented With Gentle-UHT Donor Milk

NCT04492579 · View on ClinicalTrials.gov ↗

Study Summary

This study evaluates the effects of providing breastfeeding mothers with Gentle-UHT donor human milk (GHM) after discharge to bridge the gap during delayed onset lactation, to support an exclusive human milk diet and continued breastfeeding through the infant's first week of life. The investigators aim to determine the safety of GHM, and if GHM provided to breastfeeding mothers of outpatient babies with early weight loss will ensure babies adequately gain weight according to age-matched controls.

Interventions

  • OTHER Gentle-UHT donor human milk supplementation

Study Locations (1)

Florida

  • LactaLogics, Inc. — Port Saint Lucie

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2018-08-03
Est. Completion 2020-01-17
Phase NA

Sponsor

LactaLogics

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04492579

The ClinicalTrials.gov registry entry for NCT04492579 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 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is LactaLogics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Breast Milk Expression appearing as the primary indexed condition, and to 1 intervention — of which Gentle-UHT donor human milk supplementation 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: NCT04492579 reports 1 study location spanning 1 distinct geographic area — top geographies include Florida. 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 NCT04492579 about?

NCT04492579 is a clinical study titled "Newborns Supplemented With Gentle-UHT Donor Milk". This study evaluates the effects of providing breastfeeding mothers with Gentle-UHT donor human milk (GHM) after discharge to bridge the gap during delayed onset lactation, to support an exclusive human milk diet and continued breastfeeding through the infant's first week of life. The investigators ...

What is the current status of trial NCT04492579?

This trial is currently completed. It is a NA study. The enrollment target is 31 participants. The study started on 2018-08-03. Estimated completion is 2020-01-17.

What conditions does trial NCT04492579 study?

This clinical trial studies the following conditions: Breast Milk Expression, Newborns. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04492579?

The interventions under investigation include: Gentle-UHT donor human milk supplementation (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04492579?

This trial is sponsored by LactaLogics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04492579 being conducted?

This trial has 1 study location across Florida. 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