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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06207071
Status
Recruiting
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Conditions

  • Infant Malnutrition
  • Light-For-Dates With Signs of Fetal Malnutrition
  • Nutrition Disorder, Infant
  • Premature

Eligibility Criteria

Sex
ALL
Age
24 Hours - 72 Hours
Healthy Volunteers
Accepted

Interventions

  • DHA — DIETARY_SUPPLEMENT
    DHA supplementation

Study Details

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.

Key Dates

Start date
May 20, 2024
Status verified
Jun 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
152 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Intervention
    A DHA/ARA supplement will be added to expressed human milk or donor human milk administered during the first 3 weeks after birth.
  • No Intervention: Control
    No DHA/ARA supplement will be added to expressed human milk or donor human milk administered during the first 3 weeks after birth.

Primary Outcome Measure

Head circumference at 36 weeks postmenstrual age or discharge [ Time Frame: Birth to 36 weeks postmenstrual age or discharge ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Ariel A. Salas, MD, MSPH

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University of Alabama at Birmingham· Birmingham, AL

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