Long-term Effects and Safety of DHA+AA Supplementation in Toddlerhood for Children Born Preterm
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Sarah Keim
- 入组人数
- 377
- 试验地点
- 1
- 主要终点
- Core Language Score (Clinical Evaluation of Language Fundamentals, Fifth edition-CELF-5)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous participation in Omega Tots (NCT01576783).
- •Current age of 8 years, 180 days to 10 years, 180 days.
排除标准
- •Child in custody of children's services for their window of eligibility
研究组 & 干预措施
Docosahexaenoic Acid + Arachidonic Acid
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
干预措施: Docosahexaenoic Acid + Arachidonic Acid (DHA+AA) (Drug)
Placebo
Corn oil supplement
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Core Language Score (Clinical Evaluation of Language Fundamentals, Fifth edition-CELF-5)
时间窗: 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.
Executive Function (NIH Toolbox)
时间窗: 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..
General Cognitive Ability Score(Differential Ability Scales, Second Edition-DAS-II)
时间窗: 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.
Core Language Score (Clinical Evaluation of Language Fundamentals, Fifth Edition-CELF-5)
时间窗: 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.
次要结局
- Anthropometrics-Body Composition (weight)(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)(A single study visit when the child is between 8.5 years to 10.5 years)
- 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)
- National Survey of Children's Health Module(A single study visit when the child is between 8.5 years to 10.5 years)
- Emotion Regulation Checklist(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)
- Select subscales from the Teacher Report Form 6-18(A single study visit when the child is between 8.5 years to 10.5 years)
- Anthropometrics-Adiposity(A single study visit when the child is between 8.5 years to 10.5 years)
- Child Behavior Checklist 6-18 (CBCL)(A single study visit when the child is between 8.5 years to 10.5 years)
- NIH Toolbox Friendship Fixed Form(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(A single study visit when the child is between 8.5 years to 10.5 years)
- Child Sleep Habits Questionnaire-abbreviated measure(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)
- Behavior Rating Inventory of Executive Function, 2nd Edition (BRIEF-2)(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(A single study visit when the child is between 8.5 years to 10.5 years)
- Child Behavior Checklist 6-18 (CBCL) - Competence(A single study visit when the child is between 8.5 years to 10.5 years)
- National Survey of Children's Health Module - Learning Disability(A single study visit when the child is between 8.5 years to 10.5 years)
- Emotion Regulation Checklist - Emotion Regulation(A single study visit when the child is between 8.5 years to 10.5 years)
- Child Sleep Habits Questionnaire-abbreviated Measure(A single study visit when the child is between 8.5 years to 10.5 years)
- Child Behavior Checklist 6-18 (CBCL) - Problems(A single study visit when the child is between 8.5 years to 10.5 years)
- National Survey of Children's Health Module - Developmental Delay(A single study visit when the child is between 8.5 years to 10.5 years)
- National Survey of Children's Health Module - INtellectual Disability(A single study visit when the child is between 8.5 years to 10.5 years)
- National Survey of Children's Health Module - Speech or Other Language Disorder(A single study visit when the child is between 8.5 years to 10.5 years)
- National Survey of Children's Health Module - Behavioral or Conduct Problems(A single study visit when the child is between 8.5 years to 10.5 years)
- Emotion Regulation Checklist - Lability/Negativity(A single study visit when the child is between 8.5 years to 10.5 years)
研究者
Sarah Keim
Principal Investigator
Nationwide Children's Hospital