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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.

项目摘要/摘要 Omega-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被认为对神经发育有好处。然而，关于这方面的临床试验是有限的，尤其是在早产儿童中(美国每10名儿童中就有1名)他们有更高的认知缺陷风险。我们的目前正在进行的5R01HD100493研究了180天DHA加花生四烯酸的效果 1岁时补充营养对9-10岁早产儿认知结果的影响。儿科在美国，精神障碍正在上升，早产儿童出现这些结果的风险更高。它抑郁和焦虑的症状可能会减缓补充剂的潜在益处这类障碍的认知结果此前曾与较差的执行功能有关，但这一点仍未被探索。此外，一些试验还发现了补充omega-3对情绪有益的证据。和焦虑症。然而，这些试验时间很短，旨在治疗被诊断为而不是预防疾病。迫切需要了解抑郁症和焦虑症症状是补充剂对年龄认知结果潜在有益影响的调节因素 9-10并确定在生命早期补充DHA是否有长期的预防作用儿童时期的抑郁和焦虑症状。本拟议行政补编的目标是，根据消耗臭氧层物质PA-20-277提交的，是为了确定抑郁和焦虑样症状是否在1岁时补充DHA对一般认知能力影响的调节因素(效果修饰物)， 9-10岁时的语言和执行功能，并评估补充剂是否会阻止抑郁和焦虑症状和诊断至9-10岁。理由是，它将提供身份识别可能/可能不会受益于早期DHA补充的儿童亚组，并将澄清是否补充剂可以通过追求两个目标来预防心理健康结果：1)评估抑郁和焦虑儿童期中期的相关症状和诊断可作为长期治疗的潜在调节因素(效果调节剂) 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 9-10岁时的功能；2)评估1岁时补充DHA(与安慰剂相比)对抑郁和焦虑相关症状和诊断的纵向出现从儿童早期到年龄9-10岁。该方法是对儿童长期认知和心理健康结果的检查。来自一项幼儿时期补充DHA的随机对照试验，并在使用多种... 告密者报告以及来自各种临床环境的数据。这一贡献是重大的，因为它的对主持人的关注将促进认知结果的治疗匹配/定制，并可能提供儿童心理健康结局的低成本、低负担预防性干预的证据。