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

NCT ID: NCT06207071

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-20
• Study Completion Date: 2026-12-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention

A DHA/ARA supplement will be added to expressed human milk or donor human milk administered during the first 3 weeks after birth.

Group Type: ACTIVE_COMPARATOR

DHA

Intervention Type: DIETARY_SUPPLEMENT

DHA supplementation

Control

No DHA/ARA supplement will be added to expressed human milk or donor human milk administered during the first 3 weeks after birth.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

DHA

DHA supplementation

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 24 Hours
• Maximum Eligible Age: 72 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mead Johnson Nutrition

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Ariel A. Salas

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ariel A Salas, MD, MSPH

Role: CONTACT

asalas@uab.edu

205-934-4680

Facility Contacts

Ariel A. Salas, MD, MSPH

Role: primary

Other Identifiers

300012038

Identifier Type: -

Identifier Source: org_study_id