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

Not Applicable

Recruiting

• Conditions: Premature; Infant Malnutrition; Light-For-Dates With Signs of Fetal Malnutrition; Nutrition Disorder, Infant
• Interventions: Dietary Supplement: DHA

• Registration Number: NCT06207071
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-05
• Study First Submitted QC: 2024-01-05
• Study First Posted: 2024-01-16
• Status Verified: 2024-05
• Study Start: 2024-05-20
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-28
• Primary Completion: 2026-01
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 152

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Head circumference at 36 weeks postmenstrual age or discharge	Birth to 36 weeks postmenstrual age or discharge	Declines in head circumference z scores from birth to 36 weeks postmenstrual age

Secondary Outcome Measures

Name	Time	Method
Fat mass(FM)-for-age Z-score	Birth to 36 weeks postmenstrual age	FM accretion will be estimated by air displacement plethysmography
Changes in serum metabolic profile at 36 weeks postmenstrual age	36 weeks postmenstrual age or discharge	Determined by metabolomic analyses of serum samples

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States