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

Premature Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06207071
• Other study ID #: 300012038
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2024
• Est. completion date: April 2026

Study information

• Verified date: May 2024
• Source: University of Alabama at Birmingham
• Contact: Ariel A Salas, MD, MSPH
• Phone: 205-934-4680
• Email: asalas[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: April 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Hours to 72 Hours

Eligibility

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

Related Conditions & MeSH terms

• Infant Malnutrition
• Infant Nutrition Disorders
• Malnutrition
• Nutrition Disorder, Infant
• Nutrition Disorders
• Premature

Intervention

Dietary Supplement:
• DHA
DHA supplementation

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Mead Johnson Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cognitive outcomes	Determined by Bayley assessment	2 years of age
Primary	Head circumference at 36 weeks postmenstrual age or discharge	Declines in head circumference z scores from birth to 36 weeks postmenstrual age	Birth to 36 weeks postmenstrual age or discharge
Secondary	Fat mass(FM)-for-age Z-score	FM accretion will be estimated by air displacement plethysmography	Birth to 36 weeks postmenstrual age
Secondary	Changes in serum metabolic profile at 36 weeks postmenstrual age	Determined by metabolomic analyses of serum samples	36 weeks postmenstrual age or discharge