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.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
3R01HD053055-04S1
Application #
7935127
Study Section
Special Emphasis Panel (ZRG1-ICP2-B (50))
Program Officer
Wright, Linda
Project Start
2009-09-30
Project End
2011-09-29
Budget Start
2009-09-30
Budget End
2011-09-29
Support Year
4
Fiscal Year
2009
Total Cost
$222,039
Indirect Cost
Name
University of Alabama Birmingham
Department
Pediatrics
Type
Schools of Medicine
DUNS #
063690705
City
Birmingham
State
AL
Country
United States
Zip Code
35294
Salas, Ariel A; Carlo, Waldemar A; Ambalavanan, Namasivayam et al. (2016) Gestational age and birthweight for risk assessment of neurodevelopmental impairment or death in extremely preterm infants. Arch Dis Child Fetal Neonatal Ed :
Biasini, Fred J; De Jong, Desiree; Ryan, Sarah et al. (2015) Development of a 12 month screener based on items from the Bayley II Scales of Infant Development for use in Low Middle Income countries. Early Hum Dev 91:253-8
Carlo, Waldemar A; Goudar, Shivaprasad S; Pasha, Omrana et al. (2013) Randomized trial of early developmental intervention on outcomes in children after birth asphyxia in developing countries. J Pediatr 162:705-712.e3
Manasyan, Albert; Chomba, Elwyn; McClure, Elizabeth M et al. (2011) Cost-effectiveness of essential newborn care training in urban first-level facilities. Pediatrics 127:e1176-81