Brain Research to Ameliorate Impaired Neurodevelopment-Home-based Intervention

描述（由申请人提供）：出生窒息是发展中国家新生儿死亡和发病的主要原因。出生窒息的幸存者患智力迟钝、脑瘫和其他神经发育障碍的比率很高。对照试验和荟萃分析得出结论，早期干预计划可以预防或减少许多高危婴儿的认知障碍。这些项目是美国法律规定的，也是发达国家的医疗标准。然而，发展中国家很少有早期干预方案，因此，对世界上大多数高危婴儿来说也是如此。在一个发展中国家进行的一项小型随机对照试验的初步证据表明，以家庭为基础的早期干预方案可改善出生窒息幸存者的神经发育结果（智力发育指数），但尚无结论性证据。作为由R21资助的计划拨款的一部分获得的试点数据记录了出生窒息后遗症的高发率和早期干预方案的可行性。目前的申请旨在识别有神经发育障碍风险的婴儿，并利用美国、赞比亚、印度和巴基斯坦的研究人员之间建立的多学科合作，评估发展中国家的创新早期干预计划，这些研究人员目前作为NICHD全球妇女和儿童研究网络的一部分，在复苏的FIRST BREATH多中心集群随机试验的早期阶段工作。我们将对出生后第一周通过异常神经系统检查发现的出生窒息婴儿和正常对照组进行早期干预的随机对照试验。以家庭为基础、由家长提供的早期干预将以两种方式进行试验：资源密集型和资源有限。如果在发展中国家被证明是有效的，那么以家庭为基础的早期干预计划就有可能提高全世界许多处于危险中的婴儿的认知能力，而其成本低于更昂贵的特殊教育服务。这项建议的长期目标是扩大研究合作，并建立可持续的研究能力，以预防或减少由出生窒息和其他重要原因引起的儿童神经发育障碍的神经发育后遗症。

DESCRIPTION (provided by applicant): Birth asphyxia is a leading cause of neonatal mortality and morbidity in developing countries. Survivors of birth asphyxia have high rates of mental retardation, cerebral palsy, and other neurodevelopmental disorders. Controlled trials and meta-analyses conclude that early intervention programs prevent or minimize cognitive impairment in many high-risk infants. These programs are legislatively mandated in the United States and are the standard of care in developed nations. However, early intervention programs are rarely available in developing countries and thus, to most at-risk infants worldwide. Preliminary evidence from a small randomized controlled trial conducted in a developing country suggests that a program of home-based early intervention improves neurodevelopmental outcome (Mental Developmental Index) in survivors of birth asphyxia but conclusive evidence is not available. Pilot data obtained as part of a planing grant funded by an R21 documented the high prevelence of sequelae for birth asphyxia and feasibility of an early intervention program. The current application aims to identify infants at risk for neurodevelopmental disorders and to evaluate an innovative early intervention program in developing countries utilizing established multidisciplinary collaborations between researchers in the US, Zambia, India, and Pakistan who currently work as part of the NICHD Global Network for Women's and Children's Research on an early phase of the FIRST BREATH multicenter cluster randomized trial on resuscitation. A randomized controlled trial of early intervention will be performed in infants with birth asphyxia identified by abnormal neurological exam during the first week after birth and in normal a comparison group. A home-based, parent-provided, early intervention will be tested in two delivery modes: resource-intensive and resource-limited. If proven effective in developing countries, a home-based early intervention program has the potential of improving cognitive capacity in many at-risk infants worldwide at a cost lower than more expensive special education services. The long term goal of this proposal is to broaden research collaborations and to build sustainable capacity for research to prevent or reduce neurodevelopmental sequelae resulting from birth asphyxia and other important causes of neurodevelopmental impairment in children.