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| Descriptive Information Fields | |||||||||
| Brief Title † | BRAIN - Home Intervention Trial | ||||||||
| Official Title † | 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 | ||||||||
| Brief Summary | 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). |
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| Detailed Description | |||||||||
| Study Phase | Phase IV | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Single Blind (Caregiver), Single Group Assignment | ||||||||
| Primary Outcome Measure † | neurodevelopmental outcome [ Time Frame: 36 months ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | 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. [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: No ] The effects of EI in infants with and without birth asphyxia will be moderated by child and family characteristics. [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: No ] |
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| Condition † | Asphyxia | ||||||||
| Intervention † | Other: Early intervention counseling Other: Health education counseling |
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| MEDLINE PMIDs | |||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 240 | ||||||||
| Start Date † | June 2007 | ||||||||
| Completion Date | June 2010 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria: - |
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| Gender | Both | ||||||||
| Ages | up to 28 Days | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† |
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| Location Countries † | India, Pakistan, Zambia | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00639184 | ||||||||
| Organization ID | CP04 | ||||||||
| Secondary IDs †† | HD 40636 | ||||||||
| Study Sponsor † | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||||||
| Verification Date | December 2007 | ||||||||
| First Received Date † | March 18, 2008 | ||||||||
| Last Updated Date | October 28, 2008 | ||||||||
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