DHA + AA Supplements for Premature Birth Development

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Sarah Keim

Disqualifiers: Child in custody

Compensation: Varies

Number of Visits: 1

377 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a continuation study to the Omega Tots trial (NCT01576783). The purpose of this study is to follow-up with participants of the original study to determine the long-term effect a daily fatty acid dietary supplement taken during toddlerhood might have on children born preterm now that they are 8.5-10.5 years old.

Research Team

Sarah Keim, PhD

Principal Investigator

Nationwide Children's Hospital

Eligibility Criteria

This trial is for children aged between 8 years and 6 months to 10 years and 6 months who were born prematurely and took part in the original Omega Tots study. Children under the care of child services during their eligibility period cannot participate.

Inclusion Criteria

I am between 8 years, 6 months and 10 years, 6 months old.

Previous participation in Omega Tots (NCT01576783)

Exclusion Criteria

Child in custody of children's services for their window of eligibility

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Follow-up

Participants from the original Omega Tots trial are assessed for long-term effects of DHA+AA supplementation on cognitive and behavioral outcomes

Single study visit

1 visit (in-person)

Data Analysis

Data collected from the follow-up visit is analyzed to determine the long-term effects of supplementation

Ongoing

Treatment Details

Interventions

• Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
• Placebo

Trial Overview The study is examining the long-term effects of a daily dietary supplement containing fatty acids (DHA+AA) given during toddlerhood on the development of children born preterm, now that they are older.

Participant Groups

Group I: Docosahexaenoic Acid + Arachidonic Acid Experimental Treatment 1 Intervention

Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)

Group II: Placebo Placebo Group 1 Intervention

Corn oil supplement

Who Is Running the Clinical Trial?

Sarah Keim

Lead Sponsor

Trials

6

Recruited

1,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+