A Sub-study of PREDICT Neurodevelopment Protocol

Neurocognitive Development Clinical Trial

Official title:

The Neurodevelopment in Normal Children in Cambodia and Thailand

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02406768
• Other study ID #: HIV-NAT 035.4
• Status: Completed
• Phase: N/A
• First received: March 31, 2014
• Last updated: March 30, 2015
• Start date: October 2010
• Est. completion date: August 2011

Study information

• Verified date: March 2015
• Source: The HIV Netherlands Australia Thailand Research Collaboration
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 15 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neurocognitive Development

Locations

Country	Name	City	State
Cambodia	National Center for HIV/AIDS, Dermatology and STDs (NCHADS)	Phnom Penh
Cambodia	National Pediatric Hospital	Phnom Penh
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	Nakornping Hospital	Chiang Mai
Thailand	Chiangrai Regional Hospital	Chiang Rai
Thailand	Queen Savang Vadhana Memorial Hospital, Pediatric Department,	Chonburi
Thailand	Department of Pediatrics Faculty of Medicine Khon Kaen University	Khon Kaen
Thailand	Bamrasnaradura Institute	Nonthaburi

Sponsors (4)

Lead Sponsor	Collaborator
The HIV Netherlands Australia Thailand Research Collaboration	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH)

Countries where clinical trial is conducted

Cambodia,  Thailand, 

References & Publications (1)

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, V — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neurodevelopment changes (composite of cognitive, fine motor and behavioral)	measured by cognitive test, fine motor test and behavioral assessment test	up to 96 weeks	No

External Links

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