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

StatusActive, Not Recruiting
PhaseNot applicable
Started

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Record History

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  1. Minor Enrollment closed, study ongoing
    • Site details revised
    • Eligibility criteria expanded, about 4 words
  2. Notable Primary completion pushed from May 2026 to Apr 2027
    • Study completion pushed from Dec 2026 to Apr 2027
    v9
  3. Minor Re-verified, no change to tracked fieldsv8
  4. Minor Primary completion date: Jan 2026 to May 2026
    • Study completion date: Apr 2026 to Dec 2026
    v7
  5. Minor Study title revisedv6
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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2024 to May 20, 2024
    • Site details revised
    v5
  2. Minor Start date: Apr 2024 to May 2024v4
  3. Minor Start date: Mar 2024 to Apr 2024v3
  4. Minor Start date: Feb 2024 to Mar 2024v2
  1. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06207071
Lead Sponsor University of Alabama at Birmingham
Collaborators: Mead Johnson Nutrition
Conditions
(from sponsor)
Infant Malnutrition, Light-For-Dates With Signs of Fetal Malnutrition, Premature, Nutrition Disorder, Infant
Related terms Infant Nutrition Disorders, Premature Birth
Enrollment 152 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov