BRAIN - Home Intervention Trial (BRAIN-HIT)

July 29, 2014 updated by: NICHD Global Network for Women's and Children's Health

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Belgaum, India
        • JN Medical College
  • Pakistan
      • Karachi, Pakistan
        • Aga Khan University
  • Zambia
      • Lusaka, Zambia
        • University of Zambia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 4 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
neurodevelopmental outcome
Time Frame: 36 months
36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12, 24 and 36 months
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
12, 24 and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

March 18, 2008

First Submitted That Met QC Criteria

March 18, 2008

First Posted (Estimate)

March 20, 2008

Study Record Updates

Last Update Posted (Estimate)

July 31, 2014

Last Update Submitted That Met QC Criteria

July 29, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP04
  • HD 40636

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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