Recruiting

DHA Supplementation

Sponsor:

University of Alabama at Birmingham

Code:

NCT06207071

Conditions

Infant Malnutrition

Light-For-Dates With Signs of Fetal Malnutrition

Premature

Nutrition Disorder, Infant

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

DHA

Study Details

Brief 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

Infant Malnutrition

Light-For-Dates With Signs of Fetal Malnutrition

Premature

Nutrition Disorder, Infant

Study ID

NCT06207071

Start date

May 20, 2024

Status verified date

Jun, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

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 Design

Enrollment

152 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

DHA

DHA supplementation

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Ariel A Salas, MD, MSPH

205-934-4680asalas@uab.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-06-15.