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NCT06207071 · ClinicalTrials.gov registry record · NA

Early DHA/ARA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial

A NA study of Premature and Nutrition Disorder, Infant, sponsored by University of Alabama at Birmingham.

Recruiting
Registry status
NA
Development phase
152
Enrollment target
1
Study location

NCT06207071 is a NA study of Premature and Nutrition Disorder, Infant that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 152 participants, below the 197-participant average among 4 other Premature trials with a reported enrollment target (23% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06207071, a NA study of Premature and Nutrition Disorder, Infant, is actively recruiting participants, sponsored by University of Alabama at Birmingham.

RECRUITING
Registry status
NA
Development phase
152 participants
Enrollment target
1
Study location

Study Summary

Growth-restricted very preterm infants (VPT) are born without adequate fat mass (FM) deposits and low docosahexaenoic acid (DHA) concentrations. They often experience further declines in DHA concentrations during the initial three weeks post-birth while advancing enteral feeds and receiving lipid supplementation predominantly through parenteral nutrition. These suboptimal enteral and parenteral nutrition practices significantly heighten the risk of faltering postnatal growth. One promising approach to mitigate these issues is enteral DHA supplementation. However, it remains unclear whether the early administration of DHA through enteral supplementation could lead to a more substantial increase in head growth without affecting FM accretion in growth-restricted VPT infants. To address this question, we propose a masked randomized clinical trial involving 152 VPT infants.

Interventions

  • DIETARY_SUPPLEMENT DHA

Study Locations (1)

Alabama

  • University of Alabama at Birmingham - Birmingham

Trial Details

FieldValue
Enrollment Target 152 participants
Start Date 2024-05-20
Est. Completion 2026-12
Phase NA

Sponsor

University of Alabama at Birmingham

1,160 total trials

What the Registry Record Tells You About NCT06207071

The ClinicalTrials.gov registry entry for NCT06207071 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 152 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 197-participant average among 4 other Premature trials with a reported enrollment target (23% 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 4 conditions, with Premature appearing as the primary indexed condition, and to 1 intervention - of which DHA is the first listed.

NCT06207071 reports 1 study location spanning 1 distinct geographic area - top geographies include Alabama.

Frequently Asked Questions

What is clinical trial NCT06207071 about?

NCT06207071 is a clinical study titled "Early DHA/ARA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial". Growth-restricted very preterm infants (VPT) are born without adequate fat mass (FM) deposits and low docosahexaenoic acid (DHA) concentrations. They often experience further declines in DHA concentrations during the initial three weeks post-birth while advancing enteral feeds and receiving lipid su...

What is the current status of trial NCT06207071?

This trial is currently recruiting. It is a NA study. The enrollment target is 152 participants. The study started on 2024-05-20. Estimated completion is 2026-12.

What conditions does trial NCT06207071 study?

This clinical trial studies the following conditions: Premature, Nutrition Disorder, Infant, Infant Malnutrition, Light-For-Dates With Signs of Fetal Malnutrition.

What interventions are being tested in trial NCT06207071?

The interventions under investigation include: DHA (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT06207071?

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

Where is trial NCT06207071 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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