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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00639184 |
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).
Condition | Intervention | Phase |
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Asphyxia |
Other: Early intervention counseling Other: Health education counseling |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Caregiver), Single Group Assignment |
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 |
Estimated Enrollment: | 240 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Home intervention program
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Other: Early intervention counseling
Bi-monthly home visits by counselor
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2: Active Comparator
health education counseling
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Other: Health education counseling
World Health Education health education counseling program at home visits,twice per month
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Ages Eligible for Study: | up to 28 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
-
Contact: Elizabeth McClure | 919-316-3773 | mcclure@rti.org |
India | |
JN Medical College | Recruiting |
Belgaum, India | |
Contact: Shiva Goudar sgoudar@jnmc.edu | |
Principal Investigator: Shiva Goudar | |
Pakistan | |
Aga Khan University | Recruiting |
Karachi, Pakistan | |
Contact: Omrana Pasha omrana.pasha@aku.edu | |
Principal Investigator: Omrana Pasha | |
Zambia | |
University of Zambia | Recruiting |
Lusaka, Zambia | |
Contact: Elwyn Chomba echomba@zamnet.zm | |
Principal Investigator: Elwyn Chomba |
Study Director: | Linda Wright | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Principal Investigator: | Wally A Carlo | University of Alabama at Birmingham |
Responsible Party: | University of Alabama at Birmingham ( Wally Carlo ) |
Study ID Numbers: | CP04, HD 40636 |
Study First Received: | March 18, 2008 |
Last Updated: | October 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00639184 History of Changes |
Health Authority: | United States: Federal Government |
asphyxia neurodevelopmental outcome home counseling |
Death Wounds and Injuries Disorders of Environmental Origin Asphyxia |
Death Pathologic Processes Wounds and Injuries Disorders of Environmental Origin Asphyxia |