Omega Tots Long Term Follow-up
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Docosahexaenoic Acid + Arachidonic Acid (DHA+AA), Placebo.
- Who it may be relevant to
- Registry conditions: Preterm Birth, Child Development. Basic parameters: 8 years — 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Long-term Effects and Safety of DHA+AA Supplementation in Toddlerhood for Children Born Preterm
Overview
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).
Interventions
- Drug Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
200 mg DHA+ 200 mg AA per day for 6 months - Dietary supplement Placebo
400 mg corn oil per day for 6 months
Primary outcome measures
- General Cognitive Ability Score(Differential Ability Scales, Second Edition-DAS-II) [Time frame: 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) [Time frame: A single study visit when the child is between 8.5 years to 10.5 years]
- Executive Function (NIH Toolbox) [Time frame: A single study visit when the child is between 8.5 years to 10.5 years]
Secondary outcome measures (12)
- Grooved Pegboard Task [Time frame: 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) [Time frame: 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) [Time frame: A single study visit when the child is between 8.5 years to 10.5 years]
- Anthropometrics-Body Composition (height) [Time frame: A single study visit when the child is between 8.5 years to 10.5 years]
- Anthropometrics-Body Composition (weight) [Time frame: A single study visit when the child is between 8.5 years to 10.5 years]
- Anthropometrics-Adiposity [Time frame: A single study visit when the child is between 8.5 years to 10.5 years]
- Behavior Rating Inventory of Executive Function, 2nd edition (BRIEF-2) [Time frame: A single study visit when the child is between 8.5 years to 10.5 years]
- Select subscales from the Teacher Report Form 6-18 [Time frame: A single study visit when the child is between 8.5 years to 10.5 years]
- Child Behavior Checklist 6-18 (CBCL) [Time frame: A single study visit when the child is between 8.5 years to 10.5 years]
- National Survey of Children's Health Module [Time frame: A single study visit when the child is between 8.5 years to 10.5 years]
- Emotion Regulation Checklist [Time frame: A single study visit when the child is between 8.5 years to 10.5 years]
- NIH Toolbox Friendship Fixed Form [Time frame: A single study visit when the child is between 8.5 years to 10.5 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Nationwide Children's Hospital — Columbus
Identifiers
NCT: NCT05191823 · 00001037 · R01HD100493