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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06207071

Enrollment

152

Registered

2024-01-16

Start date

2024-05-20

Completion date

2027-04-01

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DIETARY_SUPPLEMENTDHA

DHA supplementation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

24 Years to 72 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Contacts

CONTACTAriel A Salas, MD, MSPH

asalas@uab.edu205-934-4680

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026