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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.

项目总结/摘要欧米茄-3二十二碳六烯酸（DHA）补充剂在有幼儿的家庭中很受欢迎因为它对神经发育有好处然而，这方面的临床试验是有限的，特别是早产儿中（美国十分之一的儿童）认知缺陷的风险增加。我们目前正在进行的拨款5 R 01 HD 100493，检查了180天的DHA加花生四烯酸的效果在前早产儿中，在1岁时补充维生素E对9-10岁时的认知结果的影响。儿科精神疾病在美国正在上升，早产儿患这些疾病的风险也在增加。它抑郁和焦虑的症状可能会减轻补充剂的潜在益处，认知结果，因为这种疾病以前与较差的执行功能有关，但这仍然未被探索。此外，一些试验发现了补充omega-3有益于情绪的证据。和焦虑症然而，这些试验时间很短，旨在治疗诊断为而不是预防疾病。我们迫切需要了解抑郁和焦虑症状是补充剂对年龄时认知结果的潜在有益影响的调节剂 9-10并确定在生命早期补充DHA是否可以对以下疾病产生长期预防作用：抑郁症和焦虑症的症状。本拟议行政补编的目的是，提交的回应ODS PA-20-277，是为了确定抑郁症和焦虑样症状是否 1岁时补充DHA对一般认知能力影响的调节剂（效果调节剂），语言和执行功能，并评估补充是否会阻止抑郁和焦虑症状和诊断到9-10岁。理由是，它将提供识别可能/可能不受益于早期DHA补充的儿童亚组，并将澄清补充剂可以通过追求2个目标来预防心理健康结果：1）评估抑郁和焦虑儿童中期的相关症状和诊断作为长期的潜在调节剂（效应调节剂） 1岁时补充DHA（与安慰剂相比）对一般认知能力、语言和执行能力的影响 2）评估在1岁时补充DHA（与安慰剂相比）对儿童功能的影响; 抑郁和焦虑相关症状和诊断的纵向出现，从幼儿期到 9-10岁。该方法是对儿童长期认知和心理健康结果的检查从一个随机对照试验的DHA补充在幼儿期，是创新的，在其使用的多，报告以及来自各种临床环境的数据。贡献是重要的，因为它关注调节者将促进认知结果的治疗匹配/定制，并可能提供为儿童心理健康结果提供低成本低负担预防性干预的证据。