BRAIN - Home Intervention Trial (BRAIN-HIT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier:
NCT00639184
First received: March 18, 2008
Last updated: July 29, 2014
Last verified: July 2014
  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

Resource links provided by NLM:


Further study details as provided by NICHD Global Network for Women's and Children's Health:

Primary Outcome Measures:
  • neurodevelopmental outcome [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Study Completion Date: June 2010
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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639184

Locations
India
JN Medical College
Belgaum, India
Pakistan
Aga Khan University
Karachi, Pakistan
Zambia
University of Zambia
Lusaka, Zambia
Sponsors and Collaborators
NICHD Global Network for Women's and Children's Health
Investigators
Study Director: Marion Koso-Thomas, MD 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 NICHD Global Network for Women's and Children's Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier: NCT00639184     History of Changes
Other Study ID Numbers: CP04, HD 40636
Study First Received: March 18, 2008
Last Updated: July 29, 2014
Health Authority: United States: Federal Government

Keywords provided by NICHD Global Network for Women's and Children's Health:
asphyxia
neurodevelopmental outcome
home counseling

Additional relevant MeSH terms:
Asphyxia
Death
Pathologic Processes
Wounds and Injuries

ClinicalTrials.gov processed this record on September 22, 2014