Omega Tots Long Term Follow-up
Primary Purpose
Preterm Birth, Child Development
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Preterm Birth
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
Sites / Locations
- Nationwide Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Docosahexaenoic Acid + Arachidonic Acid
Placebo
Arm Description
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Corn oil supplement
Outcomes
Primary Outcome Measures
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.
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.
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..
Secondary Outcome Measures
Grooved Pegboard Task
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.
Select subtest from the Wechsler Intelligence Scales for Children, Fifth Edition (WISC-V)
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.
Select subtests from the Kaufman Test of Educational Achievement, Third Edition (KTEA-3)
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.
Anthropometrics-Body Composition (height)
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.
Anthropometrics-Body Composition (weight)
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.
Anthropometrics-Adiposity
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.
Behavior Rating Inventory of Executive Function, 2nd edition (BRIEF-2)
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 .
Select subscales from the Teacher Report Form 6-18
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.
Child Behavior Checklist 6-18 (CBCL)
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.
National Survey of Children's Health Module
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.
Emotion Regulation Checklist
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 .
NIH Toolbox Friendship Fixed Form
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.
NIH Toolbox Positive Peer Interaction Parent Report Fixed Form
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.
Child Sleep Habits Questionnaire-abbreviated measure
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 .
Full Information
NCT ID
NCT05191823
First Posted
December 21, 2021
Last Updated
December 20, 2022
Sponsor
Sarah Keim
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT05191823
Brief Title
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sarah Keim
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth, Child Development
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
377 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Docosahexaenoic Acid + Arachidonic Acid
Arm Type
Experimental
Arm Description
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Corn oil supplement
Intervention Type
Drug
Intervention Name(s)
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
Intervention Description
200 mg DHA+ 200 mg AA per day for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
400 mg corn oil per day for 6 months
Primary Outcome Measure Information:
Title
General Cognitive Ability Score(Differential Ability Scales, Second Edition-DAS-II)
Description
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.
Time Frame
A single study visit when the child is between 8.5 years to 10.5 years
Title
Core Language Score (Clinical Evaluation of Language Fundamentals, Fifth edition-CELF-5)
Description
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.
Time Frame
A single study visit when the child is between 8.5 years to 10.5 years
Title
Executive Function (NIH Toolbox)
Description
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..
Time Frame
A single study visit when the child is between 8.5 years to 10.5 years
Secondary Outcome Measure Information:
Title
Grooved Pegboard Task
Description
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.
Time Frame
A single study visit when the child is between 8.5 years to 10.5 years
Title
Select subtest from the Wechsler Intelligence Scales for Children, Fifth Edition (WISC-V)
Description
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.
Time Frame
A single study visit when the child is between 8.5 years to 10.5 years
Title
Select subtests from the Kaufman Test of Educational Achievement, Third Edition (KTEA-3)
Description
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.
Time Frame
A single study visit when the child is between 8.5 years to 10.5 years
Title
Anthropometrics-Body Composition (height)
Description
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.
Time Frame
A single study visit when the child is between 8.5 years to 10.5 years
Title
Anthropometrics-Body Composition (weight)
Description
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.
Time Frame
A single study visit when the child is between 8.5 years to 10.5 years
Title
Anthropometrics-Adiposity
Description
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.
Time Frame
A single study visit when the child is between 8.5 years to 10.5 years
Title
Behavior Rating Inventory of Executive Function, 2nd edition (BRIEF-2)
Description
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 .
Time Frame
A single study visit when the child is between 8.5 years to 10.5 years
Title
Select subscales from the Teacher Report Form 6-18
Description
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.
Time Frame
A single study visit when the child is between 8.5 years to 10.5 years
Title
Child Behavior Checklist 6-18 (CBCL)
Description
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.
Time Frame
A single study visit when the child is between 8.5 years to 10.5 years
Title
National Survey of Children's Health Module
Description
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.
Time Frame
A single study visit when the child is between 8.5 years to 10.5 years
Title
Emotion Regulation Checklist
Description
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 .
Time Frame
A single study visit when the child is between 8.5 years to 10.5 years
Title
NIH Toolbox Friendship Fixed Form
Description
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.
Time Frame
A single study visit when the child is between 8.5 years to 10.5 years
Title
NIH Toolbox Positive Peer Interaction Parent Report Fixed Form
Description
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.
Time Frame
A single study visit when the child is between 8.5 years to 10.5 years
Title
Child Sleep Habits Questionnaire-abbreviated measure
Description
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 .
Time Frame
A single study visit when the child is between 8.5 years to 10.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Keim, PhD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Omega Tots Long Term Follow-up
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