Early DHA/ARA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DHA.
- Who it may be relevant to
- Registry conditions: Infant Malnutrition, Light-For-Dates With Signs of Fetal Malnutrition, Premature, Nutrition Disorder, Infant. Basic parameters: 24 Hours — 72 Hours · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Early DHA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial
Overview
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.
Interventions
- Dietary supplement DHA
DHA supplementation
Primary outcome measures
- Head circumference at 36 weeks postmenstrual age or discharge [Time frame: Birth to 36 weeks postmenstrual age or discharge]
Secondary outcome measures (2)
- Fat mass(FM)-for-age Z-score [Time frame: Birth to 36 weeks postmenstrual age]
- Changes in serum metabolic profile at 36 weeks postmenstrual age [Time frame: 36 weeks postmenstrual age or discharge]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of Alabama at Birmingham — Birmingham
Identifiers
NCT: NCT06207071 · IRB-300012038 · 8726