Jan L. Wallander|Elizabeth M. McClure|Fred J. Biasini|Shivaprasad S. Goudar|Omrana Pasha|Elwyn Chomba|Darlene Shearer|Linda L. Wright|Vanessa Thorsten|Hrishikesh Chakraborty|Sangappa Dhaded|Niranjana Mahantshetti|Roopa Bellad|Zahid Abbasi|Waldemar A. Carlo
Brain Research to Ameliorate Impaired Neurodevelopment - Home-based Intervention Trial (BRAIN-HIT)
University of California, Merced|RTI International|University of Alabama at Birmingham|Sarojini Naidu Medical College|Aga Khan University|University Teaching Hospital|Western Kentucky University|Eunice Kennedy Shriver National Institute of Child Health and Human Development|RTI International|RTI International|Sarojini Naidu Medical College|Sarojini Naidu Medical College|Sarojini Naidu Medical College|Aga Khan University|University of Alabama at Birmingham
randomized controlled trial aims evaluate effects early developmental intervention program development young children low lowmiddleincome countries risk neurodevelopmental disability birth asphyxia group children without perinatal complications evaluated protocol compare effects early developmental intervention healthy infants communities birth asphyxia leading specific cause neonatal mortality low lowmiddleincome countries also main cause neonatal longterm morbidity including mental retardation cerebral palsy neurodevelopmental disorders mortality morbidity birth asphyxia disproportionately affect infants low lowmiddleincome countries particularly lowest socioeconomic groups evidence relatively inexpensive programs early developmental intervention delivered home visit parent trainers capable improving neurodevelopment infants following brain insult due birth asphyxia trial blockrandomized controlled trial enrolled 174 children birth asphyxia 257 without perinatal complications comparing early developmental intervention plus health safety counseling control intervention receiving health safety counseling sites india pakistan zambia interventions delivered home visits every two weeks parent trainers 2 weeks birth age 36 months primary outcome trial cognitive development secondary outcomes include socialemotional motor development child parent family characteristics number home visits completed evaluated moderating factors trial supervised trial steering committee independent data monitoring committee monitors trial findings trial potential inform strategies reducing neurodevelopmental disabilities atrisk young children low middle income countries clinicaltrialsgov nct00639184