BRAIN - Home Intervention Trial

Asphyxia Clinical Trial

— BRAIN-HIT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00639184
• Other study ID #: CP04
• Secondary ID: HD 40636
• Status: Completed
• Phase: Phase 4
• First received: March 18, 2008
• Last updated: July 29, 2014
• Start date: June 2007
• Est. completion date: June 2010

Study information

• Verified date: July 2014
• Source: NICHD Global Network for Women's and Children's Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

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:

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asphyxia

Intervention

Other:
• Early intervention counseling
Bi-monthly home visits by counselor
• Health education counseling
World Health Education health education counseling program at home visits,twice per month

Locations

Country	Name	City	State
India	JN Medical College	Belgaum
Pakistan	Aga Khan University	Karachi
Zambia	University of Zambia	Lusaka

Sponsors (1)

Lead Sponsor	Collaborator
NICHD Global Network for Women's and Children's Health

Countries where clinical trial is conducted

India,  Pakistan,  Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neurodevelopmental outcome		36 months	No
Secondary	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	No
Secondary	The effects of EI in infants with and without birth asphyxia will be moderated by child and family characteristics.		12, 24 and 36 months	No