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NCT Number: NCT06207071

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 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.

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Key information

Age range

24 hour–72 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location status: Recruiting

Location contact

Ariel A. Salas, MD, MSPH

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DHA

Dietary Supplement

DHA supplementation

Primary outcomes

  1. 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

Secondary outcomes

  1. Fat mass(FM)-for-age Z-score

    Time frame: Birth to 36 weeks postmenstrual age

    FM accretion will be estimated by air displacement plethysmography

  2. 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

Other outcomes

  1. Cognitive outcomes

    Time frame: 2 years of age

    Determined by Bayley assessment

Study contacts

Contact information is provided by the study sponsor or research team.

Ariel A Salas, MD, MSPH

CONTACT

[email protected]

205-934-4680

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Mead Johnson Nutrition

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 16, 2024
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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