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

NCT06207071 | Recruiting DMC

• 1 other identifier: 300012038
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Head circumference at 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 Outcomes (2)

• Fat mass(FM)-for-age Z-score

  Birth to 36 weeks postmenstrual age

• Changes in serum metabolic profile at 36 weeks postmenstrual age

  36 weeks postmenstrual age or discharge

Other Outcomes (1)

• Cognitive outcomes

  2 years of age

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

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 DIETARY_SUPPLEMENT

DHA supplementation

Intervention

Eligibility Criteria

• Age: 24 Hours - 72 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Mead Johnson Nutrition: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

MeSH Terms

Conditions

Infant Nutrition Disorders; Premature Birth

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Ariel A Salas, MD, MSPH

CONTACT

205-934-4680; asalas@uab.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 16, 2024
• Study Start: May 20, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

US (1)