A Sub-study of PREDICT Neurodevelopment Protocol

Completed

• Conditions: Neurocognitive Development

• Registration Number: NCT02406768
• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration

Brief Summary

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).

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 Timeline

• Study Start: 2010-10
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Study First Submitted: 2014-03-31
• Status Verified: 2015-03
• Study First Submitted QC: 2015-03-30
• Last Update Submitted: 2015-03-30
• Study First Posted: 2015-04-02
• Last Update Posted: 2015-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
neurodevelopment changes (composite of cognitive, fine motor and behavioral)	up to 96 weeks	measured by cognitive test, fine motor test and behavioral assessment test

Trial Locations

Locations (10)

National Center for HIV/AIDS, Dermatology and STDs (NCHADS); 🇰🇭 Phnom Penh, Cambodia

Bamrasnaradura Institute; 🇹🇭 Nonthaburi, Thailand

Nakornping Hospital; 🇹🇭 Chiang Mai, Thailand

Chiangrai Regional Hospital; 🇹🇭 Chiang Rai, Thailand

Pediatric Infectious Diseases Unit Department of Pediatrics Faculty of Medicine Chulalongkorn University; 🇹🇭 Bangkok, Thailand

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), The Thai Red Cross AIDS Research Center; 🇹🇭 Bangkok, Thailand

Prapokklao Hospital; 🇹🇭 Chantaburi, Thailand

Queen Savang Vadhana Memorial Hospital, Pediatric Department,; 🇹🇭 Chonburi, Thailand

Department of Pediatrics Faculty of Medicine Khon Kaen University; 🇹🇭 Khon Kaen, Thailand

National Pediatric Hospital; 🇰🇭 Phnom Penh, Cambodia