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NCT06207071NARecruitingAccepts Healthy Volunteers

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

University of Alabama at Birmingham

Start Date

5/20/2024

Completion Date

4/1/2027

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 Criteria

Age Range: No minimum to No maximum

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

Interventions

DIETARY_SUPPLEMENT

DHA

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Conditions

Infant MalnutritionLight-For-Dates With Signs of Fetal MalnutritionPrematureNutrition Disorder, Infant

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35233

United States