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NCT05191823

Omega Tots Long Term Follow-up

Enrolling by Invitation
NAAges 8–10InterventionalTreatment
Sarah Keim
~377 participants
Updated 2025-05-11 on ClinicalTrials.gov
What's tested:Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)Placebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
General Cognitive Ability Score(Differential Ability Scales, Second Edition-DAS-II)
Measured over A single study visit when the child is between 8.5 years to 10.5 years
+2 more outcomes measured

Conditions

Preterm Birth
Child Development

Explore related trials

Child DevelopmentPreterm Birth

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Sarah Keim, PhD · PRINCIPAL_INVESTIGATOR · Nationwide Children's Hospital

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Previous participation in Omega Tots (NCT01576783).
Current age of 8 years, 180 days to 10 years, 180 days.

Exclusion

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

What this trial measures

  • General Cognitive Ability Score(Differential Ability Scales, Second Edition-DAS-II)A single study visit when the child is between 8.5 years to 10.5 years

    Differential Ability Scales-II General Conceptual Ability assessment is a measure of general cognitive ability and is used to assess and identify children's cognitive strengths and weaknesses. The general cognitive ability score has a range from 30 to 170 (mean=100; SD=15). A low score indicates poor performance, and a high score indicates best performance.

  • Core Language Score (Clinical Evaluation of Language Fundamentals, Fifth edition-CELF-5)A single study visit when the child is between 8.5 years to 10.5 years

    Clinical evaluation of Language Fundamentals, 5th edition core tests is a comprehensive measure of language and can assess children's written and oral language skills, as well as their reading comprehension. The core language score has a range from 30 to 170 (mean=100; SD=15). A low score indicates poor performance, and a high score indicates best performance.

  • Executive Function (NIH Toolbox)A single study visit when the child is between 8.5 years to 10.5 years

    The NIH Toolbox Cognition Battery is a multi-dimensional set of brief measures assessing cognitive function. The Flanker, Dimensional Card Sort, and Pattern Comparison subtests measure executive function, processing speed, and attention. Standard scores have a range from 30 to 170 (mean=100; SD=15). A low score indicates poor performance, and a high score indicates best performance..