Brain Research to Ameliorate Impaired Neurodevelopment: Home-based Intervention Trial (BRAIN-HIT)

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dc.contributor.author Wallander, Jan L
dc.contributor.author McClure, Elizabeth
dc.contributor.author Biasini, Fred
dc.contributor.author Goudar, Shivaprasad
dc.contributor.author Pasha, Omrana
dc.contributor.author Chomba, Elwyn
dc.contributor.author Shearer, Darlene
dc.contributor.author Wright, Linda
dc.contributor.author Thorsten, Vanessa
dc.contributor.author Chakraborty, Hrishikesh
dc.contributor.author Dhaded, Sangappa M
dc.contributor.author Mahantshetti, Niranjana S
dc.contributor.author Bellad, Roopa M
dc.contributor.author Abbasi, Zahid
dc.contributor.author Carlo, Waldemar
dc.contributor.author [bhi], BRAIN-HIT Investigators
dc.date.accessioned 2010-06-08T19:35:48Z
dc.date.available 2010-06-08T19:35:48Z
dc.date.issued 2010-04-30
dc.identifier http://dx.doi.org/10.1186/1471-2431-10-27
dc.identifier.uri http://hdl.handle.net/2271/829
dc.description.abstract 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/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 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. 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 Clinicaltrials.gov NCT00639184
dc.title Brain Research to Ameliorate Impaired Neurodevelopment: Home-based Intervention Trial (BRAIN-HIT)
dc.type Journal Article
dc.date.updated 2010-05-17T00:04:53Z
dc.description.version Peer Reviewed
dc.language.rfc3066 en
dc.rights.holder Wallander et al.; licensee BioMed Central Ltd.

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