Clinical trial NCT02406768: A Sub-study of PREDICT Neurodevelopment Protocol
Official title: The Neurodevelopment in Normal Children in Cambodia and Thailand
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurocognitive Development
Keywords: normal controls
Lead sponsor: The HIV Netherlands Australia Thailand Research Collaboration
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Institute of Mental Health (NIMH)
First posted: 2015-04-02
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV negative unexposed and HIV-negative children born to HIV-infected mothers

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.

Eligibility criteria: 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

Primary outcomes:
measure: neurodevelopment changes (composite of cognitive, fine motor and behavioral)
timeFrame: up to 96 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Phnom Penh
country: Cambodia
facility: National Center for HIV/AIDS, Dermatology and STDs (NCHADS)
city: Phnom Penh
country: Cambodia
facility: National Pediatric Hospital
city: Bangkok
country: Thailand
facility: Pediatric Infectious Diseases Unit Department of Pediatrics Faculty of Medicine Chulalongkorn University
city: Bangkok
country: Thailand
facility: The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), The Thai Red Cross AIDS Research Center
city: Chantaburi
country: Thailand
facility: Prapokklao Hospital
city: Chiang Mai
country: Thailand
facility: Nakornping Hospital
city: Chiang Rai
country: Thailand
facility: Chiangrai Regional Hospital
city: Chonburi
country: Thailand
facility: Queen Savang Vadhana Memorial Hospital, Pediatric Department,
city: Khon Kaen
country: Thailand
facility: Department of Pediatrics Faculty of Medicine Khon Kaen University
city: Nonthaburi
country: Thailand
facility: Bamrasnaradura Institute
Study officials:
affiliation: The HIV Netherlands Australia Thailand Research Collaboration
name: Kiat Ruxrungtham, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.