A Sub-study of PREDICT Neurodevelopment Protocol

The Neurodevelopment in Normal Children in Cambodia and Thailand

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02406768

Enrollment

300

Registered

2015-04-02

Start date

2010-10-31

Completion date

2011-08-31

Last updated

2015-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurocognitive Development

Keywords

normal controls

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 15 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Cambodia, Thailand

Outcome results