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

May 7, 2026 updated by: Ariel A. Salas, University of Alabama at Birmingham

Early DHA 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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ariel A Salas, MD, MSPH
  • Phone Number: 205-934-4680
  • Email: asalas@uab.edu

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
          • Ariel A. Salas, MD, MSPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Gestational ages between 22 0/7 - 32 6/7 weeks gestation
  • < 25th centile birthweight

Exclusion Criteria:

  • Major congenital/chromosomal anomalies
  • Terminal illness in which decisions to withhold or limit support have been made

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Dietary supplement: DHA
DHA supplementation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Head circumference at 36 weeks postmenstrual age or discharge
Time Frame: Birth to 36 weeks postmenstrual age or discharge
Declines in head circumference z scores from birth to 36 weeks postmenstrual age
Birth to 36 weeks postmenstrual age or discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fat mass(FM)-for-age Z-score
Time Frame: Birth to 36 weeks postmenstrual age
FM accretion will be estimated by air displacement plethysmography
Birth to 36 weeks postmenstrual age
Changes in serum metabolic profile at 36 weeks postmenstrual age
Time Frame: 36 weeks postmenstrual age or discharge
Determined by metabolomic analyses of serum samples
36 weeks postmenstrual age or discharge

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive outcomes
Time Frame: 2 years of age
Determined by Bayley assessment
2 years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

Mead Johnson Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 5, 2024

First Submitted That Met QC Criteria

January 5, 2024

First Posted (Actual)

January 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 300012038
  • 8726 (Other Grant/Funding Number: Mead Johnson Nutrition)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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