Omega Tots Long Term Follow-up

NCT05191823 | Enrolling By Invitation

• 2 other identifiers: 00001037R01HD100493
• Study Type: interventional
• Target: 377
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preterm Birth; Child Development

Outcome Measures

Primary Outcomes (3)

• General Cognitive Ability Score(Differential Ability Scales, Second Edition-DAS-II)

  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.

  A single study visit when the child is between 8.5 years to 10.5 years

• Core Language Score (Clinical Evaluation of Language Fundamentals, Fifth edition-CELF-5)

  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.

  A single study visit when the child is between 8.5 years to 10.5 years

• Executive Function (NIH Toolbox)

  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..

  A single study visit when the child is between 8.5 years to 10.5 years

Secondary Outcomes (14)

• Grooved Pegboard Task

  A single study visit when the child is between 8.5 years to 10.5 years

• Select subtest from the Wechsler Intelligence Scales for Children, Fifth Edition (WISC-V)

  A single study visit when the child is between 8.5 years to 10.5 years

• Select subtests from the Kaufman Test of Educational Achievement, Third Edition (KTEA-3)

  A single study visit when the child is between 8.5 years to 10.5 years

• Anthropometrics-Body Composition (height)

  A single study visit when the child is between 8.5 years to 10.5 years

• Anthropometrics-Body Composition (weight)

  A single study visit when the child is between 8.5 years to 10.5 years

Study Arms (2)

Docosahexaenoic Acid + Arachidonic Acid

EXPERIMENTAL

Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)

Drug: Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)

Placebo

PLACEBO COMPARATOR

Corn oil supplement

Dietary Supplement: Placebo

Interventions

Docosahexaenoic Acid + Arachidonic Acid (DHA+AA) DRUG

200 mg DHA+ 200 mg AA per day for 6 months

Docosahexaenoic Acid + Arachidonic Acid

Placebo DIETARY_SUPPLEMENT

400 mg corn oil per day for 6 months

Placebo

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sarah Keim: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Docosahexaenoic Acids; Arachidonic Acid

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Arachidonic Acids; Eicosanoids; Fatty Acids, Essential

Study Officials

• Sarah Keim, PhD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 14, 2022
• Study Start: December 1, 2021
• Primary Completion: June 25, 2024
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

US (1)