Clinical trial NCT05191823: Omega Tots Long Term Follow-up
Official title: Long-term Effects and Safety of DHA+AA Supplementation in Toddlerhood for Children Born Preterm
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Preterm Birth
Child Development
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-01-14
Enrollment: 377
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The overall objective with the present study is to determine the long-term effects of docosahexaenoic acid (DHA) plus arachidonic acid (AA) supplementation on general cognitive ability, language, and executive function, and to examine genetic explanations for treatment effects, through one comprehensive study visit with children and parents from the Omega Tots trial cohort (NCT01576783).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: General Cognitive Ability Score(Differential Ability Scales, Second Edition-DAS-II)
timeFrame: A single study visit when the child is between 8.5 years to 10.5 years
measure: Core Language Score (Clinical Evaluation of Language Fundamentals, Fifth edition-CELF-5)
timeFrame: A single study visit when the child is between 8.5 years to 10.5 years
measure: Executive Function (NIH Toolbox)
timeFrame: A single study visit when the child is between 8.5 years to 10.5 years
Secondary outcomes:
measure: Grooved Pegboard Task
timeFrame: A single study visit when the child is between 8.5 years to 10.5 years
measure: Select subtest from the Wechsler Intelligence Scales for Children, Fifth Edition (WISC-V)
timeFrame: A single study visit when the child is between 8.5 years to 10.5 years
measure: Select subtests from the Kaufman Test of Educational Achievement, Third Edition (KTEA-3)
timeFrame: A single study visit when the child is between 8.5 years to 10.5 years
measure: Anthropometrics-Body Composition (height)
timeFrame: A single study visit when the child is between 8.5 years to 10.5 years
measure: Anthropometrics-Body Composition (weight)
timeFrame: A single study visit when the child is between 8.5 years to 10.5 years
measure: Anthropometrics-Adiposity
timeFrame: A single study visit when the child is between 8.5 years to 10.5 years
measure: Behavior Rating Inventory of Executive Function, 2nd edition (BRIEF-2)
timeFrame: A single study visit when the child is between 8.5 years to 10.5 years
measure: Select subscales from the Teacher Report Form 6-18
timeFrame: A single study visit when the child is between 8.5 years to 10.5 years
measure: Child Behavior Checklist 6-18 (CBCL)
timeFrame: A single study visit when the child is between 8.5 years to 10.5 years
measure: National Survey of Children's Health Module
timeFrame: A single study visit when the child is between 8.5 years to 10.5 years
measure: Emotion Regulation Checklist
timeFrame: A single study visit when the child is between 8.5 years to 10.5 years
measure: NIH Toolbox Friendship Fixed Form
timeFrame: A single study visit when the child is between 8.5 years to 10.5 years
measure: NIH Toolbox Positive Peer Interaction Parent Report Fixed Form
timeFrame: A single study visit when the child is between 8.5 years to 10.5 years
measure: Child Sleep Habits Questionnaire-abbreviated measure
timeFrame: A single study visit when the child is between 8.5 years to 10.5 years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Sarah Keim, PhD
role: PRINCIPAL_INVESTIGATOR
References: