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

NCT06207071

RecruitingNA

Sponsor: University of Alabama at Birmingham

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

Interventions: DHA

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 24 Hours to 72 Hours

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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
Locations (1)
  • Birmingham, Alabama, United States