BRAIN - Home Intervention Trial

Phase 4

Completed

• Conditions: Asphyxia
• Interventions: Other: Health education counseling; Other: Early intervention counseling

• Registration Number: NCT00639184
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-03-18
• Study First Submitted QC: 2008-03-18
• Study First Posted: 2008-03-20
• Primary Completion: 2010-05
• Study Completion: 2010-06
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-29
• Last Update Posted: 2014-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	Health education counseling	health education counseling
1	Early intervention counseling	Home intervention program

Primary Outcome Measures

Name	Time	Method
neurodevelopmental outcome	36 months

Secondary Outcome Measures

Name	Time	Method
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.	12, 24 and 36 months
The effects of EI in infants with and without birth asphyxia will be moderated by child and family characteristics.	12, 24 and 36 months

Trial Locations

Locations (3)

JN Medical College; 🇮🇳 Belgaum, India

Aga Khan University; 🇵🇰 Karachi, Pakistan

University of Zambia; 🇿🇲 Lusaka, Zambia