Trials / Recruiting
RecruitingNCT06207071
Early DHA/ARA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial
Early DHA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 152 (estimated)
- Sponsor
- University of Alabama at Birmingham · Academic / Other
- Sex
- All
- Age
- 24 Hours – 72 Hours
- Healthy volunteers
- Accepted
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.
Conditions
- Infant Malnutrition
- Light-For-Dates With Signs of Fetal Malnutrition
- Premature
- Nutrition Disorder, Infant
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | DHA | DHA supplementation |
Timeline
- Start date
- 2024-05-20
- Primary completion
- 2026-05-01
- Completion
- 2026-12-01
- First posted
- 2024-01-16
- Last updated
- 2025-05-30
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06207071. Inclusion in this directory is not an endorsement.