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Brain research to ameliorate impaired neurodevelopment--home-based intervention trial (BRAIN-HIT)
Jan L Wallander1, Elizabeth McClure, Fred Biasini
1Psychological Sciences and Health Sciences Research Institute, University of California, Merced, 5200 Lake Road, Merced, CA 95343, USA. jwallander@ucmerced.edu
Insights
Early developmental intervention programs can improve neurodevelopment in infants at risk for disability due to birth asphyxia in low-income countries. This study evaluated such programs, showing potential for reducing long-term neurodevelopmental disorders.
Area of Science:
- Global child health
- Developmental pediatrics
- Public health interventions
Background:
- Birth asphyxia is a primary cause of neonatal mortality and neurodevelopmental disabilities in low- and low-middle-income countries.
- Infants from lower socioeconomic groups are disproportionately affected by birth asphyxia-related mortality and morbidity.
- Early developmental intervention programs show promise in improving neurodevelopment following brain injury.
Purpose of the Study:
- To evaluate the impact of an early developmental intervention program on young children at risk for neurodevelopmental disability due to birth asphyxia.
- To compare intervention effects in at-risk infants versus healthy infants in similar communities.
- To assess the efficacy of home-visit based parent training for improving infant neurodevelopment.
Main Methods:
- A block-randomized controlled trial involving 174 children with birth asphyxia and 257 without perinatal complications.
- Interventions delivered via bi-weekly home visits by parent trainers from 2 weeks to 36 months of age.
- Primary outcome: cognitive development; Secondary outcomes: social-emotional and motor development.
Main Results:
- The study is ongoing; findings are anticipated to inform strategies for reducing neurodevelopmental disabilities.
- Data on cognitive, social-emotional, and motor development will be analyzed.
- Moderating factors such as child, parent, and family characteristics will be evaluated.
Conclusions:
- This trial has the potential to provide evidence for effective, low-cost interventions in resource-limited settings.
- Findings could guide the implementation of strategies to mitigate the long-term effects of birth asphyxia.
- The study will contribute to reducing the burden of neurodevelopmental disorders in vulnerable populations.
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.
