University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Location status: Recruiting
Location contact
Ariel A. Salas, MD, MSPH
CONTACT
NCT Number: NCT06207071
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.
Interested in participating?
Request Info24 hour–72 hour
All sexes
Interventional
Not applicable
Birmingham, Alabama, 35233, United States
Location status: Recruiting
Ariel A. Salas, MD, MSPH
CONTACT
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
DHA supplementation
Time frame: Birth to 36 weeks postmenstrual age or discharge
Declines in head circumference z scores from birth to 36 weeks postmenstrual age
Time frame: Birth to 36 weeks postmenstrual age
FM accretion will be estimated by air displacement plethysmography
Time frame: 36 weeks postmenstrual age or discharge
Determined by metabolomic analyses of serum samples
Time frame: 2 years of age
Determined by Bayley assessment
Contact information is provided by the study sponsor or research team.
University of Alabama at Birmingham
Other
Early DHA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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