RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-05-20
Study Completion:2026-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06207071

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:24 Hours to 72 Hours
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Gestational ages between 22 0/7 - 32 6/7 weeks gestation
  2. * \< 25th centile birthweight
  1. * Major congenital/chromosomal anomalies
  2. * Terminal illness in which decisions to withhold or limit support have been made

Contacts and Locations

Study Contact

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

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-20
Study Completion Date2026-04

Study Record Updates

Study Start Date2024-05-20
Study Completion Date2026-04

Terms related to this study

Additional Relevant MeSH Terms

  • Infant Malnutrition
  • Light-For-Dates With Signs of Fetal Malnutrition
  • Premature
  • Nutrition Disorder, Infant