BRAIN - Home Intervention Trial (BRAIN-HIT)
Recruitment status was Recruiting
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Purpose
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 |
|---|---|---|
|
Asphyxia |
Other: Early intervention counseling Other: Health education counseling |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Caregiver) Primary Purpose: Treatment |
| 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 |
- neurodevelopmental outcome [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- 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 ]
| 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 |
|---|---|
|
Experimental: 1
Home intervention program
|
Other: Early intervention counseling
Bi-monthly home visits by counselor
|
|
Active Comparator: 2
health education counseling
|
Other: Health education counseling
World Health Education health education counseling program at home visits,twice per month
|
Eligibility| Ages Eligible for Study: | up to 28 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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:
-
Contacts and Locations| 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 |
More Information
No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Wally Carlo, University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT00639184 History of Changes |
| Other Study ID Numbers: | CP04, HD 40636 |
| Study First Received: | March 18, 2008 |
| Last Updated: | October 28, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
asphyxia neurodevelopmental outcome home counseling |
Additional relevant MeSH terms:
|
Asphyxia Death Pathologic Processes Wounds and Injuries |
ClinicalTrials.gov processed this record on June 18, 2013