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NCT04492579 · ClinicalTrials.gov registry record · NA
Newborns Supplemented With Gentle-UHT Donor Milk
A NA study of Breast Milk Expression and Newborns, sponsored by LactaLogics.
- Completed
- Registry status
- NA
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT04492579 is a NA study of Breast Milk Expression and Newborns that has completed, run by LactaLogics. The registered enrollment target is 31 participants, below the 133-participant average among 3 other Breast Milk Expression trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04492579, a NA study of Breast Milk Expression and Newborns, has completed, sponsored by LactaLogics.
- COMPLETED
- Registry status
- NA
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
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.
Conditions Studied
Interventions
- OTHER Gentle-UHT donor human milk supplementation
Study Locations (1)
Florida
- LactaLogics, Inc. - Port Saint Lucie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2018-08-03 |
| Est. Completion | 2020-01-17 |
| Phase | NA |
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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, categorized as NA. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 133-participant average among 3 other Breast Milk Expression trials with a reported enrollment target (77% lower). The listed sponsor is LactaLogics, which has 1 total studies on file at ClinicalTrials.gov.
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.
NCT04492579 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
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.
What interventions are being tested in trial NCT04492579?
The interventions under investigation include: Gentle-UHT donor human milk supplementation (OTHER).
Who is sponsoring clinical trial NCT04492579?
This trial is sponsored by LactaLogics, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
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