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Completed

NCT Number: NCT02406768

A Sub-study of PREDICT Neurodevelopment Protocol

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).

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Key information

Age range

1 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. neurodevelopment changes (composite of cognitive, fine motor and behavioral)

    Time frame: up to 96 weeks

    measured by cognitive test, fine motor test and behavioral assessment test

Sponsors and collaborators

Lead sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Other

Collaborators

  • 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)

Registry information

Official study title

The Neurodevelopment in Normal Children in Cambodia and Thailand

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 2, 2015
Registry last updated
Apr 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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