title: Randomized trial of early developmental intervention on outcomes in children after birth asphyxia in developing countries.
abstract: OBJECTIVE
  To determine if early developmental intervention (EDI) improves developmental abilities in resuscitated children.
  
  
  METHODS
  This was a parallel group, randomized controlled trial of infants unresponsive to stimulation who received bag and mask ventilation as part of their resuscitation at birth and infants who did not require any resuscitation born in rural communities in India, Pakistan, and Zambia. Intervention infants received a parent-implemented EDI delivered with home visits by parent trainers every other week for 3 years starting the first month after birth. Parents in both intervention and control groups received health and safety counseling during home visits on the same schedule. The main outcome measure was the Mental Development Index (MDI) of the Bayley Scales of Infant Development, 2nd edition, assessed at 36 months by evaluators unaware of treatment group and resuscitation history.
  
  
  RESULTS
  MDI was higher in the EDI (102.6 ± 9.8) compared with the control resuscitated children (98.0 ± 14.6, 1-sided P = .0202), but there was no difference between groups in the nonresuscitated children (100.1 ± 10.7 vs 97.7 ± 10.4, P = .1392). The Psychomotor Development Index was higher in the EDI group for both the resuscitated (P = .0430) and nonresuscitated children (P = .0164).
  
  
  CONCLUSIONS
  This trial of home-based, parent provided EDI in children resuscitated at birth provides evidence of treatment benefits on cognitive and psychomotor outcomes. MDI and Psychomotor Development Index scores of both nonresuscitated and resuscitated infants were within normal range, independent of early intervention.
authors.affiliation: University of Alabama at Birmingham, Birmingham, AL; Center for Infectious Disease Research in Zambia, Lusaka, Zambia. wcarlo@peds.uab.edu
authors.forename: Waldemar A
authors.initials: WA
authors.lastname: Carlo
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: Jan L
authors.initials: JL
authors.lastname: Wallander
authors.forename: Fred J
authors.initials: FJ
authors.lastname: Biasini
authors.forename: Elizabeth M
authors.initials: EM
authors.lastname: McClure
authors.forename: Vanessa
authors.initials: V
authors.lastname: Thorsten
authors.forename: Hrishikesh
authors.initials: H
authors.lastname: Chakraborty
authors.forename: Dennis
authors.initials: D
authors.lastname: Wallace
authors.forename: Darlene L
authors.initials: DL
authors.lastname: Shearer
authors.forename: Linda L
authors.initials: LL
authors.lastname: Wright
mesh_terms: D001237:Asphyxia / Q000628:therapy*; D002657:Child Development; D003072:Cognition Disorders / Q000517:prevention & control; D003906:Developing Countries; D002658:Developmental Disabilities / Q000175:diagnosis*; D018479:Early Intervention, Educational / Q000379:methods*; D005260:Female; D006801:Humans; D007194:India; D007231:Infant, Newborn; D008297:Male; D010154:Pakistan; D011596:Psychomotor Disorders / Q000517:prevention & control; D012151:Resuscitation; D012424:Rural Population; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D015024:Zambia