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NCT04294368 · ClinicalTrials.gov registry record · NA
Targeted Fortification of Donor Breast Milk in Preterm Infants
A NA study of Prematurity; Extreme and Growth Failure, sponsored by Columbia University.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT04294368: Recruiting NA study of Prematurity; Extreme and Growth Failure, sponsored by Columbia University.
NCT04294368 is a NA study of Prematurity; Extreme and Growth Failure that is actively recruiting participants, run by Columbia University. The registered enrollment target is 50 participants, below the 235-participant average among 4 other Prematurity; Extreme trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04294368, a NA study of Prematurity; Extreme and Growth Failure, is actively recruiting participants, sponsored by Columbia University.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is a randomized controlled trial comparing standard fortification of donor breast milk to targeted fortification of donor breast milk in preterm infants. The purpose of the study is to determine if there is a benefit to target fortifying donor breast milk in the preterm population. The investigators hypothesize that infants receiving targeted fortification of donor breast milk will have improved growth compared to infants receiving standard fortification of donor breast milk.
Primary Outcome
Weight change in g/kg/day, z-score value, and change in z-score from week-to-week
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid
- DIETARY_SUPPLEMENT Similac Liquid Protein Fortifier
- DIETARY_SUPPLEMENT Nestle Microlipid
- DIETARY_SUPPLEMENT Medica Nutrition SolCarb
- DIETARY_SUPPLEMENT Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid (Targeted Fortification)
Study Locations (1)
New York
- Columbia University Medical Center/ New York - Presbyterian - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2020-03-09 |
| Est. Completion | 2026-03 |
| Phase | NA |
What NCT04294368 shows while recruiting
NCT04294368 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 235-participant average among 4 other Prematurity; Extreme trials with a reported enrollment target (79% lower).
The record links to 5 conditions, with Prematurity; Extreme appearing as the primary indexed condition, and to 5 interventions - of which Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid is the first listed.
NCT04294368 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04294368 about?
NCT04294368 is a clinical study titled "Targeted Fortification of Donor Breast Milk in Preterm Infants". This study is a randomized controlled trial comparing standard fortification of donor breast milk to targeted fortification of donor breast milk in preterm infants. The purpose of the study is to determine if there is a benefit to target fortifying donor breast milk in the preterm population. The in...
What is the current status of trial NCT04294368?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2020-03-09. Estimated completion is 2026-03.
What conditions does trial NCT04294368 study?
This clinical trial studies the following conditions: Prematurity; Extreme, Growth Failure, Growth Retardation, Failure to Thrive in Newborn, Infant Nutrition Disorders.
What interventions are being tested in trial NCT04294368?
The interventions under investigation include: Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid (DIETARY_SUPPLEMENT), Similac Liquid Protein Fortifier (DIETARY_SUPPLEMENT), Nestle Microlipid (DIETARY_SUPPLEMENT), Medica Nutrition SolCarb (DIETARY_SUPPLEMENT), Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid (Targeted Fortification) (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04294368?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04294368 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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