BRAIN - Home Intervention Trial

NCT00639184 | Completed Phase 4 DMC

• 2 other identifiers: CP04HD 40636
• Study Type: interventional
• Target: 240
• Locations: 3 countries
• Sites: 3

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).

Conditions

Asphyxia

Keywords

asphyxia; neurodevelopmental outcome; home counseling

Outcome Measures

Primary Outcomes (1)

• neurodevelopmental outcome

  36 months

Secondary Outcomes (2)

• 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

Study Arms (2)

1

EXPERIMENTAL

Home intervention program

Other: Early intervention counseling

2

ACTIVE COMPARATOR

health education counseling

Other: Health education counseling

Interventions

Early intervention counseling OTHER

Bi-monthly home visits by counselor

1

Health education counseling OTHER

World Health Education health education counseling program at home visits,twice per month

2

Eligibility Criteria

• Age: 1 Minute - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• NICHD Global Network for Women's and Children's Health: lead

Study Sites (3)

JN Medical College

Belagavi, India

Location

Aga Khan University

Karachi, Pakistan

Location

University of Zambia

Lusaka, Zambia

Location

Related Publications (2)

• Carlo WA, Goudar SS, Pasha O, Chomba E, McClure EM, Biasini FJ, Wallander JL, Thorsten V, Chakraborty H, Wright LL; Brain Research to Ameliorate Impaired Neurodevelopment-Home-based Intervention Trial Committee; National Institute of Child Health and Human Development Global Network for Women's and Children's Health Research. Neurodevelopmental outcomes in infants requiring resuscitation in developing countries. J Pediatr. 2012 May;160(5):781-5.e1. doi: 10.1016/j.jpeds.2011.10.007. Epub 2011 Nov 17.

  PMID: 22099522 DERIVED

• Wallander JL, McClure E, Biasini F, Goudar SS, Pasha O, Chomba E, Shearer D, Wright L, Thorsten V, Chakraborty H, Dhaded SM, Mahantshetti NS, Bellad RM, Abbasi Z, Carlo W; BRAIN-HIT Investigators. Brain research to ameliorate impaired neurodevelopment--home-based intervention trial (BRAIN-HIT). BMC Pediatr. 2010 Apr 30;10:27. doi: 10.1186/1471-2431-10-27.

  PMID: 20433740 DERIVED

MeSH Terms

Conditions

Asphyxia

Condition Hierarchy (Ancestors)

Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Marion Koso-Thomas, MD

  Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  STUDY DIRECTOR

• Wally A Carlo

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2008
• First Posted: March 20, 2008
• Study Start: June 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 31, 2014

Record last verified: 2014-07

Locations

PA (1); ZA (1); IN (1)