title: Brain research to ameliorate impaired neurodevelopment--home-based intervention trial (BRAIN-HIT).
abstract: BACKGROUND
  This randomized controlled trial aims to evaluate the effects of an early developmental intervention program on the development of young children in low- and low-middle-income countries who are at risk for neurodevelopmental disability because of birth asphyxia. A group of children without perinatal complications are evaluated in the same protocol to compare the effects of early developmental intervention in healthy infants in the same communities. Birth asphyxia is the leading specific cause of neonatal mortality in low- and low-middle-income countries and is also the main cause of neonatal and long-term morbidity including mental retardation, cerebral palsy, and other neurodevelopmental disorders. Mortality and morbidity from birth asphyxia disproportionately affect more infants in low- and low-middle-income countries, particularly those from the lowest socioeconomic groups. There is evidence that relatively inexpensive programs of early developmental intervention, delivered during home visit by parent trainers, are capable of improving neurodevelopment in infants following brain insult due to birth asphyxia.
  
  
  METHODS
  This trial is a block-randomized controlled trial that has enrolled 174 children with birth asphyxia and 257 without perinatal complications, comparing early developmental intervention plus health and safety counseling to the control intervention receiving health and safety counseling only, in sites in India, Pakistan, and Zambia. The interventions are delivered in home visits every two weeks by parent trainers from 2 weeks after birth until age 36 months. The primary outcome of the trial is cognitive development, and secondary outcomes include social-emotional and motor development. Child, parent, and family characteristics and number of home visits completed are evaluated as moderating factors.
  
  
  CONCLUSIONS
  The trial is supervised by a trial steering committee, and an independent data monitoring committee monitors the trial. Findings from this trial have the potential to inform about strategies for reducing neurodevelopmental disabilities in at-risk young children in low and middle income countries.
authors.affiliation: Psychological Sciences and Health Sciences Research Institute, University of California, Merced, 5200 Lake Road, Merced, CA 95343, USA. jwallander@ucmerced.edu
authors.forename: Jan L
authors.initials: JL
authors.lastname: Wallander
authors.forename: Elizabeth
authors.initials: E
authors.lastname: McClure
authors.forename: Fred
authors.initials: F
authors.lastname: Biasini
authors.forename: Shivaprasad S
authors.initials: SS
authors.lastname: Goudar
authors.forename: Omrana
authors.initials: O
authors.lastname: Pasha
authors.forename: Elwyn
authors.initials: E
authors.lastname: Chomba
authors.forename: Darlene
authors.initials: D
authors.lastname: Shearer
authors.forename: Linda
authors.initials: L
authors.lastname: Wright
authors.forename: Vanessa
authors.initials: V
authors.lastname: Thorsten
authors.forename: Hrishikesh
authors.initials: H
authors.lastname: Chakraborty
authors.forename: Sangappa M
authors.initials: SM
authors.lastname: Dhaded
authors.forename: Niranjana S
authors.initials: NS
authors.lastname: Mahantshetti
authors.forename: Roopa M
authors.initials: RM
authors.lastname: Bellad
authors.forename: Zahid
authors.initials: Z
authors.lastname: Abbasi
authors.forename: Waldemar
authors.initials: W
authors.lastname: Carlo
mesh_terms: D001237:Asphyxia / Q000150:complications; D035843:Biomedical Research; D001921:Brain / Q000254:growth & development*; D002657:Child Development; D002675:Child, Preschool; D003071:Cognition; D002658:Developmental Disabilities / Q000453:epidemiology / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D018479:Early Intervention, Educational / Q000379:methods* / Q000706:statistics & numerical data; D004644:Emotions; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007194:India / Q000453:epidemiology; D007223:Infant; D008297:Male; D009043:Motor Activity; D010154:Pakistan / Q000453:epidemiology; D010290:Parents / Q000193:education; D016896:Treatment Outcome; D015024:Zambia / Q000453:epidemiology