Open Access Study protocol

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

Jan L Wallander1*, 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 and the BRAIN-HIT Investigators

Author Affiliations

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

2 Department of Statistics and Epidemiology, RTI International, 3040 Cornwallis Road, Durham, NC 27709, USA

3 Department of Psychology, University of Alabama at Birmingham, 1530 3rd Avenue South, Birmingham, AL 35294, USA

4 Departments of Physiology and Medical Education, J N Medical College, Belgaum, 590 010 Karnataka, India

5 Departments of Community Health Sciences and Family Medicine, Aga Kahn University, Stadium Road, Karachi 74800, Pakistan

6 University Teaching Hospital, Private Bag RW1X, Lusaka, Zambia

7 Department of Public Health, Western Kentucky University, 1906 College Heights Blvd, AC 129A, Bowling Green, KY 42101, USA

8 Center for Research for Mothers and Children, Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6100 Executive Blvd., Room 4B05J, Rockville, MD 20852, USA

9 Department of Pediatrics, J. N. Medical College, Belgaum, 590 010 Karnataka, India

10 Division of Neonatology, Department of Pediatrics, University of Alabama at Birmingham, 619 South 20th Street, Birmingham, AL 35233-7335, USA

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BMC Pediatrics 2010, 10:27  doi:10.1186/1471-2431-10-27

Published: 30 April 2010



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.


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.


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