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Wallander et al. BMC Pediatrics 2010, 10:27

Study protocol

Open Access

Brain Research to Ameliorate Impaired Neurodevelopment - Home-based Intervention Trial (BRAIN-HIT)
Jan L Wallander*1, Elizabeth McClure2, Fred Biasini3, Shivaprasad S Goudar4, Omrana Pasha5, Elwyn Chomba6, Darlene Shearer7, Linda Wright8, Vanessa Thorsten2,Hrishikesh Chakraborty2, Sangappa M Dhaded9, Niranjana S Mahantshetti9, Roopa M Bellad9, Zahid Abbasi5, Waldemar Carlo10 for the BRAIN-HIT Investigators

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 forneurodevelopmental 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 morbidityincluding 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 parenttrainers, are capable of improving neurodevelopment in infants following brain insult due to birth asphyxia. Methods/Design: 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 safetycounseling 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 socialemotional and motor development. Child, parent, and family characteristics and number of home visits completed areevaluated as moderating factors. Discussion: 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. Trial Registration: NCT00639184 BackgroundResearch justification

Birth asphyxia, or failure to initiate spontaneous respiration, is the leading specific cause of neonatal mortality in low- and low-middle income countries (L/LMIC) and accounts for about one million the four million neonatal
* Correspondence:

Psychological Sciences and Health Sciences Research Institute, University of California, Merced,5200 Lake Road, Merced, CA 95343, USA

Full list of author information is available at the end of the article

deaths that occur each year worldwide [1]. Birth asphyxia is also the main cause of neonatal encephalopathy [1-3] and long-term morbidity including intellectual disability, cerebral palsy, and other neurodevelopmental disorders [2-4]. Mortality and morbidity from birth asphyxiadisproportionately affect more infants in L/LMIC, particularly those from the lowest socioeconomic groups [5]. Therefore, neonatal resuscitation is being implemented through formal training programs in many L/LMIC [6,7]. Although improving resuscitation in L/LMIC may save

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