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NCT04325308 · ClinicalTrials.gov registry record · NA
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
A NA study of Microbial Colonization and Prematurity; Extreme, sponsored by University of Alabama at Birmingham.
- Active
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT04325308 is a NA study of Microbial Colonization and Prematurity; Extreme that is active but no longer recruiting, run by University of Alabama at Birmingham. The registered enrollment target is 150 participants, below the 12,647-participant average among 20 other Microbial Colonization trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04325308, a NA study of Microbial Colonization and Prematurity; Extreme, is active but no longer recruiting, sponsored by University of Alabama at Birmingham.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
The central hypothesis of this clinical trial is that, in extremely preterm infants, protein-enriched human milk diets compared to usual human milk diets during the first 2 weeks after birth increase fat-free mass (FFM)-for-age Z scores and promote maturation of the gut microbiome at term corrected age.
Conditions Studied
Interventions
- PROCEDURE Protein-enriched human milk diet
- PROCEDURE Usual human milk diet
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2020-08-13 |
| Est. Completion | 2026-09-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04325308
The ClinicalTrials.gov registry entry for NCT04325308 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,647-participant average among 20 other Microbial Colonization trials with a reported enrollment target (99% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Microbial Colonization appearing as the primary indexed condition, and to 2 interventions - of which Protein-enriched human milk diet is the first listed.
NCT04325308 reports 1 study location spanning 1 distinct geographic area - top geographies include Alabama.
Frequently Asked Questions
What is clinical trial NCT04325308 about?
NCT04325308 is a clinical study titled "Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk". The central hypothesis of this clinical trial is that, in extremely preterm infants, protein-enriched human milk diets compared to usual human milk diets during the first 2 weeks after birth increase fat-free mass (FFM)-for-age Z scores and promote maturation of the gut microbiome at term corrected ...
What is the current status of trial NCT04325308?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2020-08-13. Estimated completion is 2026-09-30.
What conditions does trial NCT04325308 study?
This clinical trial studies the following conditions: Microbial Colonization, Prematurity; Extreme, Growth Failure, Breast Milk Expression, Feeding Disorder Neonatal.
What interventions are being tested in trial NCT04325308?
The interventions under investigation include: Protein-enriched human milk diet (PROCEDURE), Usual human milk diet (PROCEDURE).
Who is sponsoring clinical trial NCT04325308?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04325308 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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