Long-term Effects and Safety of DHA Supplementation in Toddlerhood for Children born Preterm - Administrative Supplement

学步期补充 DHA 对早产儿的长期影响和安全性 - 行政补充

基本信息

批准号：
10727669
负责人：
Sarah Keim
金额：
$ 15.6万
依托单位：
RESEARCH INST NATIONWIDE CHILDREN'S HOSP
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-08-01 至 2025-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10727669
关键词：
1 year old Administrative Supplement Adolescence Adolescent Affect Age Anxiety Anxiety Disorders Arachidonic Acids Attention Brain Child Child Welfare Childhood Clinical Clinical Trials Cognition Cognitive Cognitive deficits Data Development Diagnosis Diet Disease Dopamine Early Diagnosis Early identification Family Fatty Acids Goals Grant Health Impaired health Impairment Intervention Knowledge Language Life Literature Long-Term Effects Major Depressive Disorder Membrane Mental Depression Mental Health Mental disorders Mission Mood Disorders Motivation Neurons Norepinephrine Omega-3 Fatty Acids Only Child Outcome Parents Physicians Placebos Population Population Group Premature Infant Preventive Preventive treatment Public Health Randomized Randomized, Controlled Trials Reporting Research Risk Role Safety Serotonin Special Population Subgroup Supplementation Symptoms Weaning Well in self anxiety symptoms child depression childhood anxiety cognitive ability cost depressive symptoms design dietary supplements early childhood effective intervention executive function experience fatty acid supplementation follow-up improved informant innovation lens neurodevelopment prevent preventive intervention response symptom treatment teacher tool transmission process

项目摘要

PROJECT SUMMARY/ABSTRACT Omega-3 docosahexaenoic fatty acid (DHA) supplementation is popular among families with young children due to its perceived benefits for neurodevelopment. However, clinical trials on this are limited, particularly among children born preterm (1 in 10 children in the U.S.) who are at increased risk of cognitive deficits. Our ongoing current grant, 5R01HD100493, examines the effects of 180-day DHA plus arachidonic acid supplementation at age 1 year on cognitive outcomes at age 9-10 among former preterm infants. Pediatric psychiatric disorders are rising in the US, and children born preterm are at increased risk of these outcomes. It is plausible that symptoms of depression and anxiety may moderate the supplements potential benefits on cognitive outcomes as such disorders have previously been associated with poorer executive function, but this remains unexplored. Further, some trials have found evidence of omega-3 supplementation benefits in mood and anxiety disorders. However, these trials were short and designed to treat symptoms of diagnosed disorders rather than prevent them. There is a critical need to understand whether depression and anxiety symptoms are moderators of the supplementation’s potentially beneficial effects on cognitive outcomes at age 9-10 and to determine examine if DHA supplementation in early life can have long-term preventive effects on depression and anxiety symptoms in childhood. The objective of this proposed Administrative Supplement, submitted in response to ODS PA-20-277, is to determine whether depression and anxiety-like symptoms are a moderator (effect modifier) of the effect of DHA supplementation at age 1 on general cognitive ability, language and executive function at age 9-10, and to assess if supplementation prevents the development of depression and anxiety symptoms and diagnoses to age 9-10. The rationale is that it will offer identification of subgroups of children that may/may not benefit from early DHA supplementation, and will clarify if supplementation can prevent mental health outcomes by pursuing 2 aims: 1) Evaluate depression and anxiety related symptoms and diagnoses in mid-childhood as potential moderators (effect modifiers) of the long-term effect of DHA supplementation (vs placebo) at age 1 on general cognitive ability, language and executive function at age 9-10; 2) Evaluate the effect of DHA supplementation (compared to placebo) at age 1 on the longitudinal emergence of depression and anxiety related symptoms and diagnoses from early childhood to age 9-10. The approach is an examination of the long-term cognitive and mental health outcomes of children from a randomized controlled trial of DHA supplementation in toddlerhood, and is innovative in its use of multi- informant reports as well as data from a variety of clinical settings. The contribution is significant in that its focus on moderators will facilitate treatment matching/tailoring for cognitive outcomes, and potentially provide evidence for a low-cost low-burden preventive intervention for pediatric mental health outcomes.

项目摘要/摘要 Omega-3 Docosahexaenoic脂肪酸（DHA）补充剂在有孩子的家庭中很受欢迎由于其对神经发育的益处。但是，对此进行临床试验是有限的，特别是在出生的早产儿（美国十分之一的儿童）中，患有认知缺陷的风险增加。我们的目前正在进行的赠款（5R01HD100493）检查了180天DHA加蛛形酸的影响在前早产儿中，以9-10岁的认知结果为1岁。小儿在美国，精神疾病正在上升，而出生的早产儿则有这些结果的风险增加。它合理的是，抑郁和动画的符号可能会减轻补充的潜在收益认知结果作为此类疾病以前与执行功能较差有关，但是仍然出乎意料。此外，一些试验发现了情绪中补充omega-3的证据和焦虑症。但是，这些试验很短，旨在治疗诊断症状疾病而不是阻止它们。迫切需要了解抑郁和动画是否症状是补充对认知结果的潜在有益影响的主持人 9-10并确定检查早期补充DHA是否会对童年时期的抑郁症和焦虑症状。该提议的行政补充的目的，根据ODS PA-20-277提交的是确定抑郁症和类似动画的符号是 1岁时补充DHA对一般认知能力的影响的主持人（效应修饰符）， 9-10岁的语言和执行功能，并评估补充是否阻止抑郁症和动画症状以及9-10岁的诊断。理由是它将提供可能/可能无法从早期补充DHA中受益的儿童子组，并会澄清是否存在补充可以通过追求2个目标来防止心理健康结果：1）评估抑郁和动画与长期的潜在主持人（效应修饰符）相关的符号和诊断 DHA补充（VS安慰剂）在1岁时对一般认知能力，语言和执行 9-10岁的功能； 2）评估1岁时DHA补充（与安慰剂相比）对抑郁和动画相关症状的纵向出现，从幼儿到诊断到 9-10岁。该方法是对儿童的长期认知和心理健康成果的检查从幼儿园中DHA补充的随机对照试验中线人报告以及来自各种临床环境的数据。贡献很重要，因为它专注于主持人将促进认知结果的治疗匹配/裁缝，并有可能提供小儿心理健康结果的低成本预防性干预的证据。