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Omega Tots 长期随访

2026年7月20日 更新者:Sarah Keim

早产儿幼儿期补充 DHA+AA 的长期效果和安全性

这是 Omega Tots 试验 (NCT01576783) 的延续研究。 本研究的目的是跟进原始研究的参与者,以确定在学步期每天服用脂肪酸膳食补充剂可能对 8.5-10.5 岁的早产儿产生的长期影响。

研究概览

详细说明

本研究的总体目标是确定补充二十二碳六烯酸 (DHA) 加花生四烯酸 (AA) 对一般认知能力、语言和执行功能的长期影响,并检查治疗效果的遗传解释,通过一项对来自 Omega Tots 试验队列 (NCT01576783) 的儿童和父母进行综合研究访问。

研究类型

介入性

注册 (实际的)

377

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ohio
      • Columbus、Ohio、美国、43205
        • Nationwide Children's Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

4年 至 6年 (孩子)

接受健康志愿者

不

描述

纳入标准:

  • 曾参与 Omega Tots (NCT01576783)。
  • 当前年龄8岁180天到10岁180天。

排除标准:

  • 受儿童服务监护的儿童的资格窗口

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的:二十二碳六烯酸+花生四烯酸
二十二碳六烯酸 + 花生四烯酸 (DHA+AA)
每天 200 毫克 DHA+ 200 毫克 AA,持续 6 个月
安慰剂比较:安慰剂
玉米油补充剂
每天 400 毫克玉米油,持续 6 个月

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
一般认知能力评分(差异能力量表,第二版-DAS-II)
大体时间:当孩子在 8.5 岁到 10.5 岁之间时进行一次研究访问
Differential Ability Scales-II General Conceptual Ability 评估是一般认知能力的量度,用于评估和识别儿童的认知优势和劣势。 一般认知能力得分的范围为 30 至 170(平均值 = 100;SD = 15)。 低分表示性能差,高分表示性能最好。
当孩子在 8.5 岁到 10.5 岁之间时进行一次研究访问
执行函数(NIH 工具箱)
大体时间:当孩子在 8.5 岁到 10.5 岁之间时进行一次研究访问
NIH Toolbox Cognition Battery 是一套评估认知功能的多维简要措施。 Flanker、Dimensional Card Sort 和 Pattern Comparison 子测试测量执行功能、处理速度和注意力。 标准分数的范围从 30 到 170(平均值 = 100;SD = 15)。 低分表示性能差,高分表示性能最好。
当孩子在 8.5 岁到 10.5 岁之间时进行一次研究访问
Core Language Score (Clinical Evaluation of Language Fundamentals, Fifth Edition-CELF-5)
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
凹槽钉板任务
大体时间:当孩子在 8.5 岁到 10.5 岁之间时进行一次研究访问
Grooved Pegboard 任务通过要求孩子将钉子插入木板来测量手眼协调能力和运动速度。 分数是放置钉子的时间。 如果孩子达到 3 分钟的时间限制,则分数就是放置的木桩数。 更快的时间和更少的钉子掉落表示更好的性能。
当孩子在 8.5 岁到 10.5 岁之间时进行一次研究访问
人体测量学-肥胖
大体时间:当孩子在 8.5 岁到 10.5 岁之间时进行一次研究访问
为了评估儿童的肥胖,使用生物电阻抗来测量体脂百分比。 儿童的身高和体重将合并报告 BMI (kg/m^2)。 这些测量值根据世界卫生组织的儿童生长标准转换为年龄和性别的 z 分数。 z 分数表示偏离均值的标准差数。 z 分数为 0 等于参考人群(相同年龄和性别的儿童)的平均值。 小于 0 的值表示低于参考总体的值,而大于 0 的值表示高于参考总体的值。
当孩子在 8.5 岁到 10.5 岁之间时进行一次研究访问
NIH 工具箱友谊固定表格
大体时间:当孩子在 8.5 岁到 10.5 岁之间时进行一次研究访问
NIH 工具箱友谊(8-17 岁)固定表格是一个包含 5 个项目的问卷,用于衡量同伴关系并评估过去一个月与朋友和其他熟人的关系质量。 分数将表示为 t 分数(范围 = [16-68];平均值 = 50;SD = 10),其中较高的分数表示更强的同伴关系。
当孩子在 8.5 岁到 10.5 岁之间时进行一次研究访问
NIH 工具箱积极的同伴互动家长报告固定表格
大体时间:当孩子在 8.5 岁到 10.5 岁之间时进行一次研究访问
NIH 工具箱积极同伴互动表(3-12 岁)是一份包含 4 个项目的问卷,通过家长报告衡量儿童同伴关系。 分数将表示为 t 分数(范围= [-8-63] ;平均值=50;SD=10),其中较高的分数表示较强的同伴关系。
当孩子在 8.5 岁到 10.5 岁之间时进行一次研究访问
Select Subtest From the Wechsler Intelligence Scales for Children, Fifth Edition (WISC-V)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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
Behavior Rating Inventory of Executive Function, 2nd Edition (BRIEF-2)
大体时间: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
大体时间: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) - Competence
大体时间: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 score. 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.
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
大体时间: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 or not (yes, no).
A single study visit when the child is between 8.5 years to 10.5 years
Emotion Regulation Checklist - Emotion Regulation
大体时间: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 Emotion Regulation scale (range=10-40). Higher scores on the Emotion Regulation scale indicates more ability to regulate
A single study visit when the child is between 8.5 years to 10.5 years
Child Sleep Habits Questionnaire-abbreviated Measure
大体时间: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
Child Behavior Checklist 6-18 (CBCL) - Problems
大体时间: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 problem scores. T 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 - Developmental Delay
大体时间: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 or not (yes, no).
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
大体时间: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 or not (yes, no).
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
大体时间: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 or not (yes, no).
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
大体时间: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 or not (yes, no).
A single study visit when the child is between 8.5 years to 10.5 years
Emotion Regulation Checklist - Lability/Negativity
大体时间: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 a Lability/Negativity (range=14-56) scale. 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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Sarah Keim, PhD、Nationwide Children's Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年12月1日

初级完成 (实际的)

2024年6月25日

研究完成 (估计的)

2027年6月30日

研究注册日期

首次提交

2021年12月21日

首先提交符合 QC 标准的

2022年1月10日

首次发布 (实际的)

2022年1月14日

研究记录更新

最后更新发布 (实际的)

2026年8月11日

上次提交的符合 QC 标准的更新

2026年7月20日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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