BRAIN - Home Intervention Trial (BRAIN-HIT)

NICHD Global Network for Women's and Children's Health

Status and phase

Completed

Phase 4

Conditions

Asphyxia

Treatments

Other: Early intervention counseling

Other: Health education counseling

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT00639184

HD 40636

CP04

Details and patient eligibility

About

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).

Enrollment

240 estimated patients

Sex

All

Ages

1 minute to 28 days old

Volunteers

Accepts Healthy Volunteers

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