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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 3 days
Healthy Volunteers: t
View:

• Gestational ages between 22 0/7 - 32 6/7 weeks gestation

• \< 25th centile birthweight

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Contact Information
Primary
Ariel A Salas, MD, MSPH
asalas@uab.edu
205-934-4680
Time Frame
Start Date: 2024-05-20
Estimated Completion Date: 2026-12
Participants
Target number of participants: 152
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Alabama at Birmingham
Collaborators: Mead Johnson Nutrition

This content was sourced from clinicaltrials.gov