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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: Recruiting NA study of Premature and Nutrition Disorder, Infant, sponsored by University of Alabama at Birmingham.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Declines in head circumference z scores from birth to 36 weeks postmenstrual age
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT DHA
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2024-05-20 |
| Est. Completion | 2026-12 |
| Phase | NA |
What NCT06207071 shows while recruiting
NCT06207071 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, below the 197-participant average among 4 other Premature trials with a reported enrollment target (23% lower).
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 a single indexed study location in 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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