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BRAIN - Home Intervention Trial (BRAIN-HIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00639184
Recruitment Status : Completed
First Posted : March 20, 2008
Last Update Posted : July 31, 2014
Information provided by (Responsible Party):
NICHD Global Network for Women's and Children's Health

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).

Condition or disease Intervention/treatment Phase
Asphyxia Other: Early intervention counseling Other: Health education counseling Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Care Provider)
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
Study Start Date : June 2007
Actual Primary Completion Date : May 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. neurodevelopmental outcome [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00639184

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JN Medical College
Belgaum, India
Aga Khan University
Karachi, Pakistan
University of Zambia
Lusaka, Zambia
Sponsors and Collaborators
NICHD Global Network for Women's and Children's Health
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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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: NICHD Global Network for Women's and Children's Health Identifier: NCT00639184    
Other Study ID Numbers: CP04
HD 40636
First Posted: March 20, 2008    Key Record Dates
Last Update Posted: July 31, 2014
Last Verified: July 2014
Keywords provided by NICHD Global Network for Women's and Children's Health:
neurodevelopmental outcome
home counseling
Additional relevant MeSH terms:
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Pathologic Processes
Wounds and Injuries