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.
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