Neurocognitive DevelopmentNCT02406768
A Sub-study of PREDICT Neurodevelopment Protocol
An observational study of Neurocognitive Development, run by The HIV Netherlands Australia Thailand Research Collaboration at 10 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 1 year to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurocognitive Development
- How many people
- 300 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Oct 2010to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: HIV negative unexposed and HIV-negative children born to HIV-infected mothers
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Thailand8 sites
Pediatric Infectious Diseases Unit Department of Pediatrics Faculty of Medicine Chulalongkorn University
Bangkok, Bangkok, 10330
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), The Thai Red Cross AIDS Research Center
Bangkok, Bangkok, 10330
Prapokklao Hospital
Chanthaburi, Changwat Chanthaburi, 22000
Nakornping Hospital
Chiang Mai, Chiang Mai, 50180
Chiangrai Regional Hospital
Chiang Rai, Changwat Chiang Rai, 57000
Queen Savang Vadhana Memorial Hospital, Pediatric Department,
Chon Buri, Changwat Chon Buri, 20110
Department of Pediatrics Faculty of Medicine Khon Kaen University
Khon Kaen, Changwat Khon Kaen, 40002
Bamrasnaradura Institute
Nonthaburi, Changwat Nonthaburi, 11000
Cambodia2 sites
National Center for HIV/AIDS, Dermatology and STDs (NCHADS)
Phnom Penh
National Pediatric Hospital
Phnom Penh
About this study
Official title: The Neurodevelopment in Normal Children in Cambodia and Thailand
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).
Read the 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.
- Conditions
- Neurocognitive Development
- Keywords
- normal controls
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV negative unexposed | HIV negative controls | |
| HIV negative exposed | HIV-negative children born to HIV-infected mothers |
What is being measured
The primary outcome is the main question the study is designed to answer.
neurodevelopment changes (composite of cognitive, fine motor and behavioral)
measured by cognitive test, fine motor test and behavioral assessment test
Measured: up to 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startOct 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurocognitive DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Kiat Ruxrungtham, MD, Principal investigator, The HIV Netherlands Australia Thailand Research Collaboration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02406768
- Sponsor's protocol ID
- HIV-NAT 035.4
- Status last verified
- Mar 2015
- First submitted
- 31 Mar 2014
- Last updated
- 2 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23263176
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neurodevelopment in Normal Children in Cambodia and Thailand
- ClinicalTrials.gov ID
- NCT02406768
- Acronym / sponsor ID
- HIV-NAT 035.4
- Conditions
- Neurocognitive Development
- Keywords
- normal controls
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
- Study start
- Oct 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 2 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV negative unexposed | – | –HIV negative controls |
| HIV negative exposed | – | –HIV-negative children born to HIV-infected mothers |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- HIV negative unexposed and HIV-negative children born to HIV-infected mothers
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2015.
- Results publication: PubMed 23263176Puthanakit 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.
- HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kiat Ruxrungtham, MD principal investigator
The HIV Netherlands Australia Thailand Research Collaboration
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurocognitive Development, run by The HIV Netherlands Australia Thailand Research Collaboration at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Thailand, Cambodia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neurodevelopment changes (composite of cognitive, fine motor and behavioral) (time frame: up to 96 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02406768, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2015.