Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study of Breast Milk Expression and Newborns, sponsored by LactaLogics.
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 118-participant average among 4 other Breast Milk Expression trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Average weights compared to WHO data
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 |
What the finished NCT04492579 record still lists
NCT04492579 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 118-participant average among 4 other Breast Milk Expression trials with a reported enrollment target (74% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Breast Milk Expression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Galactagogue Use in Lactating Women With Low Milk Supply
RECRUITING · NA
-
Pumping to Up Maternal Milk Production for Preterms
RECRUITING · NA
-
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
ACTIVE NOT RECRUITING · NA
-
Targeting Human Milk Fortification to Improve Preterm Infant Growth and Brain Development
ACTIVE NOT RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02932618 · 31 participants · Phase 3
A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD)
- NCT03482297 · 31 participants · Phase 1
Automated Abdominal Binder for Orthostatic Hypotension
- NCT04016389 · 31 participants · NA
FIGO 2018 Stage IB2 Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery
- NCT04211675 · 31 participants · Phase 1
NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI