- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05191823
Omega Tots Long Term Follow-up
December 19, 2023 updated by: Sarah Keim
Long-term Effects and Safety of DHA+AA Supplementation in Toddlerhood for Children Born Preterm
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Estimated)
377
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ohio
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Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 8 years (Child)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Docosahexaenoic Acid + Arachidonic Acid
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
|
200 mg DHA+ 200 mg AA per day for 6 months
|
Placebo Comparator: Placebo
Corn oil supplement
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400 mg corn oil per day for 6 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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)
Time Frame: 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.
|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Grooved Pegboard Task
Time Frame: A single study visit when the child is between 8.5 years to 10.5 years
|
The Grooved Pegboard task measures eye-hand coordination and motor speed by requiring children to insert pegs into a board.
The score is the time to place the pegs.
If the child reaches the time limit of 3 minutes, then the score is the number of pegs placed.
A faster time and lower number of pegs dropped is indicative of better performance.
|
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
|
The Weschler Intelligence Scales for Children-V Digit Span and Picture Span subtests assess working memory.
The working memory index composite score has a range from 30-170 (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
|
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
|
The Kaufman Test of Educational Achievement-3 is an assessment of key academic skills.
The Letter and Word Recognition, Math Computation, Object Naming Facility, and Associative Fluency Subtests measure children's reading, math, and written language skills.
The standard score has a range from 30-170 (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
|
Anthropometrics-Body Composition (height)
Time Frame: A single study visit when the child is between 8.5 years to 10.5 years
|
To assess children's body composition, height (in centimeters) is measured.
This is converted to a z score for age and sex based on Child Growth Standards from the World Health Organization.
The z score indicates the number of standard deviations away from the mean.
A z score of 0 is equal to the mean of a reference population (children the same age and sex).
Values less than 0 indicate values lower than the reference population, while values greater than 0 indicate values higher than the reference population.
|
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
|
To assess children's body composition, weight (in kilograms) is measured.
This is converted to a z score for age and sex based on Child Growth Standards from the World Health Organization.
The z score indicates the number of standard deviations away from the mean.
A z score of 0 is equal to the mean of a reference population (children the same age and sex).
Values less than 0 indicate values lower than the reference population, while values greater than 0 indicate values higher than the reference population.
|
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
|
To assess children's adiposity, a bioelectric impedance is used to measure body fat percent.
Child's height and weight will be combined to report BMI (kg/m^2).
These measurements are converted to a z score for age and sex based on Child Growth Standards from the World Health Organization.
The z score indicates the number of standard deviations away from the mean.
A z score of 0 is equal to the mean of a reference population (children the same age and sex).
Values less than 0 indicate values lower than the reference population, while values greater than 0 indicate values higher than the reference population.
|
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
|
The Behavior Rating Inventory of Executive Function, 2nd ed., is completed by the child's caregiver and teacher to measure a range of executive functioning capabilities in children.
The BRIEF-2 yields nine clinical scales that measure various aspects of executive function plus three broad indices: behavioral regulation, emotion regulation, and cognitive regulation.
Scores are summed to obtain a Global Executive Composite Score that will be expressed as a t score (range= [35-90]; (mean=50; SD=10), where a higher score indicates greater dysregulation .
|
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
|
The Teacher Report Form (syndrome and DSM-Oriented subscales) is completed by the child's teacher to reflect on the child's behavior in the previous six months.
Scores are summed to provide a total problems score.
Scores are also computed to measure the following subscales: internalizing problems, externalizing problems, anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behavior, aggression behavior, affective problems, anxiety problems, somatic problems, attention deficit/hyperactivity problems, oppositional defiant problems, conduct problems.
Scores will be expressed as a t-score (range= [33-100]; mean=50; SD=10), where a lower score indicates a more optimal outcome.
|
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
|
The Child Behavior Checklist is completed by the child' caregiver to reflect their child's behavior in the previous six months.
Scores were summed to provide total competence and problem scores.
Total competence scores will be expressed as a t-score (range= [20-100]; mean=50; SD=10), where a higher score reflects a more optimal outcome.
Problem scores will be expressed as a t-score (range= [25,100]; mean=50; SD=10), where a lower score reflects a more optimal outcome.
|
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
|
The National Survey of Children's Health module captures child developmental and behavioral diagnoses and other major diagnoses via parent report .
A binary variable will be formed to indicate if a child has been diagnosed with each condition.
|
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
|
The Emotion Regulation Checklist is completed by the child's caregiver to measure child's ability to manage their emotions.
Scores are grouped and summed to yield two scales: Emotion Regulation (range=10-40) and Lability/Negativity (range=14-56).
Higher scores on the Emotion Regulation scale indicates more ability to regulate, whereas higher scores on the Lability/Negativity scale reflect greater dysregulation .
|
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
|
The NIH Toolbox Friendship (Ages 8-17) Fixed Form is a 5-item questionnaire that measures peer relationships and assesses the quality of relationships with friends and other acquaintances over the past month.
Scores will be expressed as a t-score (range= [16-68]; mean=50; SD=10), where a higher score indicates stronger peer relationships.
|
A single study visit when the child is between 8.5 years to 10.5 years
|
NIH Toolbox Positive Peer Interaction Parent Report Fixed Form
Time Frame: A single study visit when the child is between 8.5 years to 10.5 years
|
The NIH Toolbox Positive Peer Interaction Form (Ages 3-12) is a 4-item questionnaire that measures child peer relationships via parent report.
Scores will be expressed as a t-score (range= [-8-63] ; mean=50; SD=10), where a higher score indicates stronger peer relationships.
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A single study visit when the child is between 8.5 years to 10.5 years
|
Child Sleep Habits Questionnaire-abbreviated measure
Time Frame: A single study visit when the child is between 8.5 years to 10.5 years
|
The Child Sleep Habits Questionnaire-abbreviated measures child sleep pattern and behaviors via parent report.
Parents are asked to report on the child's bedtime behavior, sleep duration, and behavior during sleep.
Scores are summed to give the total sleep disturbance score (range 33-99).
Scores are also grouped and summed to yield eight subscales that measure different aspects of sleep.
A higher score is indicative of more sleep problems .
|
A single study visit when the child is between 8.5 years to 10.5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sarah Keim, PhD, Nationwide Children's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2021
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
December 21, 2021
First Submitted That Met QC Criteria
January 10, 2022
First Posted (Actual)
January 14, 2022
Study Record Updates
Last Update Posted (Actual)
December 20, 2023
Last Update Submitted That Met QC Criteria
December 19, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00001037
- R01HD100493 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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