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NCT05525585 · ClinicalTrials.gov registry record · NA

Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants

A NA study of Prematurity and Enteral Feeding Intolerance, sponsored by University of Alabama at Birmingham.

Active
Registry status
NA
Development phase
80
Enrollment target
1
Study location

NCT05525585 is a NA study of Prematurity and Enteral Feeding Intolerance that is active but no longer recruiting, run by University of Alabama at Birmingham. The registered enrollment target is 80 participants, below the 207-participant average among 21 other Prematurity trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05525585, a NA study of Prematurity and Enteral Feeding Intolerance, is active but no longer recruiting, sponsored by University of Alabama at Birmingham.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
80 participants
Enrollment target
1
Study location

Study Summary

In this proposed clinical trial, the investigators will randomize 80 very preterm (VPT) infants to receive either early (between day 4 and 7) or delayed (between day 10 and 14) fortification and determine if providing early protein supplementation through early fortification results in higher FFM-for-age z scores and more diversity in the gut microbiome.

Interventions

  • DIETARY_SUPPLEMENT Early HMF
  • DIETARY_SUPPLEMENT Delayed HMF

Study Locations (1)

Alabama

  • University of Alabama at Birmingham - Birmingham

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2022-11-17
Est. Completion 2026-05
Phase NA

Sponsor

University of Alabama at Birmingham

1,160 total trials

What the Registry Record Tells You About NCT05525585

The ClinicalTrials.gov registry entry for NCT05525585 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 207-participant average among 21 other Prematurity trials with a reported enrollment target (61% 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 3 conditions, with Prematurity appearing as the primary indexed condition, and to 2 interventions - of which Early HMF is the first listed.

NCT05525585 reports 1 study location spanning 1 distinct geographic area - top geographies include Alabama.

Frequently Asked Questions

What is clinical trial NCT05525585 about?

NCT05525585 is a clinical study titled "Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants". In this proposed clinical trial, the investigators will randomize 80 very preterm (VPT) infants to receive either early (between day 4 and 7) or delayed (between day 10 and 14) fortification and determine if providing early protein supplementation through early fortification results in higher FFM-fo...

What is the current status of trial NCT05525585?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2022-11-17. Estimated completion is 2026-05.

What conditions does trial NCT05525585 study?

This clinical trial studies the following conditions: Prematurity, Enteral Feeding Intolerance, Light-For-Dates.

What interventions are being tested in trial NCT05525585?

The interventions under investigation include: Early HMF (DIETARY_SUPPLEMENT), Delayed HMF (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT05525585?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05525585 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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