BRAIN - Home Intervention Trial

Study Overview
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Brief Summary
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We plan to test a home-based parent-provided early developmental intervention (EI) both in infants with mild to moderate birth asphyxia and in infants without perinatal complications who will constitute a healthy comparison group in a randomized controlled trial. The trial will evaluate the effect of a resource-intensive early intervention (EI) program on the outcomes in infants born in rural communities in Zambia, India, and Pakistan. It will consist of frequent interaction (every 2 weeks the first year and every 4 weeks the second and third years) between parents and the parent trainer. The control group will receive enhanced health counseling (HC). The overall goal will be to implement and evaluate an EI program for infants following birth asphyxia, which is sustainable in developing countries. The challenge will be to adapt programs demonstrated to be effective in developed countries to the circumstances of the developing world, while reducing the demands on resources. Because there are limited data on normative development and EI programs in developing countries, a group of infants without perinatal complications will also be randomized to the same conditions in order to provide a comparison of what may be achieved from the intervention in healthy infants in developing countries. A final aim will be to address individual variation in EI effects that could be due to child and/or family characteristics. A randomized controlled experimental design will be used, in which infants who survive following birth asphyxia are randomly assigned to either EI or enhanced health education counseling (HC). The trial will randomize infants to a home-based parent-provided early developmental intervention (EI) with frequent home interaction between parents and parent trainers vs. HC. A group of infants without birth asphyxia or other major perinatal complications also will be randomized. Children will be examined by masked examiners at three time points (12, 24, and 36 month's assessments).

Official Title
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Brain Research to Ameliorate Impaired Neurodevelopment (BRAIN): Home-based Intervention A Multicenter Trial of the Global Network for Women's and Children's Health Research

Conditions
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Asphyxia

Intervention / Treatment
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* Other: Early intervention counseling
* Other: Health education counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: birth asphyxia birth weight of at least 1,500g neurological examination consistent with normal, Stage I or II on the Ellis scale (Ellis, et al. 2000) willing to participate in an intervention program for 36 months. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Home intervention program | Other: Early intervention counseling<br>* Bi-monthly home visits by counselor<br>|
| Active Comparator: 2<br>health education counseling | Other: Health education counseling<br>* World Health Education health education counseling program at home visits,twice per month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neurodevelopmental outcome |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The improvements in cognitive, social, and motor development will be larger in the infants who have had birth asphyxia compared to those without birth asphyxia. |  | 12, 24 and 36 months | 
| The effects of EI in infants with and without birth asphyxia will be moderated by child and family characteristics. |  | 12, 24 and 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asphyxia, neurodevelopmental outcome, home counseling