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Early DHA/ARA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial
NCT06207071 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06207071
The ClinicalTrials.gov registry entry for NCT06207071 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 152 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,315 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06207071 reports 1 study location spanning 1 distinct geographic area — top geographies include Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06207071?
The interventions under investigation include: DHA (DIETARY_SUPPLEMENT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06207071?
This trial is sponsored by University of Alabama at Birmingham, which has 1,315 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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