BRAIN - Home Intervention Trial — BRAIN-HIT  

Asphyxia Clinical Trial

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

Status Completed

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).

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

• Asphyxia

• NCT number: NCT00639184
• Study type: Interventional
• Source: NICHD Global Network for Women's and Children's Health
• Status: Completed
• Phase: Phase 4
• Start date: June 2007
• Completion date: June 2010