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

The University of Alabama at Birmingham

Status: Enrolling

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

Treatments: Dietary Supplement: DHA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06207071

300012038

Details and patient eligibility

About

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.

Enrollment: 152 estimated patients

Sex: All

Ages: 24 to 72 hours old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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152 participants in 2 patient groups

Intervention

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: DHA

Control

No Intervention group

Description:

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