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

Purpose

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

Eligibility

Eligible Ages
Between 24 Hours and 72 Hours
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Dietary Supplement: DHA
    DHA supplementation
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.

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233
Contact:
Ariel A. Salas, MD, MSPH

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Ariel A Salas, MD, MSPH
205-934-4680
asalas@uab.edu