A Sub-study of PREDICT Neurodevelopment Protocol

The Neurodevelopment in Normal Children in Cambodia and Thailand

To determine the neurodevelopment (ND) in normal children in Thailand and Cambodia and to use this group to compare the neurodevelopmental changes over time to the HIV-infected children with and without HAART (main study).

Study Overview

• Status: Completed
• Conditions: Neurocognitive Development

Detailed Description

Normative data are mostly, if not exclusively, obtained from children in the Western world. Comparing data from Asian children to these norms may lead to the wrong interpretation of the results, as it does not account for cultural differences, translation issues and a possibly different education system. Therefore it is essential to include a matched control group to evaluate the participants of the study to the fullest extent in terms of cognition, memory, behavior and fine motor skills, in all age groups over the full course of the study.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Cambodia
  • Phnom Penh, Cambodia
    • National Pediatric Hospital
  • Phnom Penh, Cambodia
    • National Center for HIV/AIDS, Dermatology and STDs (NCHADS)
• Thailand
  • Bangkok, Thailand, 10330
    • Pediatric Infectious Diseases Unit Department of Pediatrics Faculty of Medicine Chulalongkorn University
  • Bangkok, Thailand, 10330
    • The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), The Thai Red Cross AIDS Research Center
  • Chantaburi, Thailand, 22000
    • Prapokklao Hospital
  • Chiang Mai, Thailand, 50180
    • Nakornping Hospital
  • Chiang Rai, Thailand, 57000
    • Chiangrai Regional Hospital
  • Chonburi, Thailand, 20110
    • Queen Savang Vadhana Memorial Hospital, Pediatric Department,
  • Khon Kaen, Thailand, 40002
    • Department of Pediatrics Faculty of Medicine Khon Kaen University
  • Nonthaburi, Thailand, 11000
    • Bamrasnaradura Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 15 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV negative unexposed and HIV-negative children born to HIV-infected mothers

Description

Inclusion Criteria: for HIV negative exposed children

• Child from a HIV-positive mother
• Documented negative test for HIV-1 infection
• Between the age from 1-15 years
• Caregiver of the subject is willing and able to sign informed consent, prior to the study
• Thai or Cambodian origin

HIV negative and not HIV exposed:

Inclusion

• Child from a HIV-negative mother (by history)
• Documented negative test for HIV-1 infection
• Between the age from 1-15 years
• Caregiver of the subject is willing and able to sign informed consent, prior to the study
• Thai or Cambodian origin

Exclusion Criteria: for HIV negative exposed children

• The inability of the caregivers to understand the nature and extend of the trial and the procedure required
• Patients with psychiatric disorder
• Patients with a syndrome that affects cognitive performance

for HIV negative and not HIV exposed

• The inability of the caregivers to understand the nature and extent of the trial and the procedure required
• Patients with psychiatric disorder
• Patients with a syndrome that affects cognitive performance

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
HIV negative unexposed; HIV negative controls
HIV negative exposed; HIV-negative children born to HIV-infected mothers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neurodevelopment changes (composite of cognitive, fine motor and behavioral)	measured by cognitive test, fine motor test and behavioral assessment test	up to 96 weeks

Collaborators and Investigators

• Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Kiat Ruxrungtham, MD, The HIV Netherlands Australia Thailand Research Collaboration

Publications and helpful links

General Publications

• Puthanakit T, Ananworanich J, Vonthanak S, Kosalaraksa P, Hansudewechakul R, van der Lugt J, Kerr SJ, Kanjanavanit S, Ngampiyaskul C, Wongsawat J, Luesomboon W, Vibol U, Pruksakaew K, Suwarnlerk T, Apornpong T, Ratanadilok K, Paul R, Mofenson LM, Fox L, Valcour V, Brouwers P, Ruxrungtham K; PREDICT Study Group. Cognitive function and neurodevelopmental outcomes in HIV-infected Children older than 1 year of age randomized to early versus deferred antiretroviral therapy: the PREDICT neurodevelopmental study. Pediatr Infect Dis J. 2013 May;32(5):501-8. doi: 10.1097/INF.0b013e31827fb19d.

Helpful Links

• HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: March 31, 2014
• First Submitted That Met QC Criteria: March 30, 2015
• First Posted (Estimate): April 2, 2015

Study Record Updates

• Last Update Posted (Estimate): April 2, 2015
• Last Update Submitted That Met QC Criteria: March 30, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: normal controls
• Other Study ID Numbers: HIV-NAT 035.4