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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Brain Research to Ameliorate Impaired Neurodevelopment - Home-based Intervention Trial (BRAIN-HIT)
BMC Pediatrics, Volume 10, Article 27, Year 2010
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Description
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. © 2010 Wallander et al; licensee BioMed Central Ltd.
Authors & Co-Authors
Wallander, Jan Lance
United States, Merced
Uc Merced
McClure, Elizabeth M.
United States, Research Triangle Park
Rti International
Biasini, Fred J.
United States, Birmingham
The University of Alabama at Birmingham
Goudar, Shivaprasad S.
India, Belgaum
Jawaharlal Nehru Medical College Belgaum
Pasha, Omrana
Pakistan, Karachi
The Aga Khan University
Chomba, Elwyn Nachanya
Zambia, Lusaka
University Teaching Hospital Lusaka
Shearer, Darlene L.
United States, Bowling Green
Western Kentucky University
Wright, Linda L.
United States, Bethesda
National Institute of Child Health and Human Development Nichd
Thorsten, Vanessa R.
United States, Research Triangle Park
Rti International
Chakraborty, Hrishikesh
United States, Research Triangle Park
Rti International
Dhaded, Sangappa Mallappa
India, Belgaum
Jawaharlal Nehru Medical College Belgaum
Mahantshetti, Niranjana S.
India, Belgaum
Jawaharlal Nehru Medical College Belgaum
Bellad, Roopa M.
India, Belgaum
Jawaharlal Nehru Medical College Belgaum
Abbasi, Zahid
Pakistan, Karachi
The Aga Khan University
Carlo, Waldemar A.
United States, Birmingham
The University of Alabama at Birmingham
Statistics
Citations: 15
Authors: 15
Affiliations: 8
Identifiers
Doi:
10.1186/1471-2431-10-27
e-ISSN:
14712431
Research Areas
Disability
Maternal And Child Health
Study Design
Randomised Control Trial
Study Approach
Quantitative
Study Locations
Zambia