1. Evaluation of neurocgnitive functioning in children with HIV in comparison with healthy siblings using questionnaires.2. Qualitative analysis of different determinants that play a role in school participation in children with HIV using interviews…
ID
Source
Brief title
Condition
- Immunodeficiency syndromes
- Viral infectious disorders
- Central nervous system infections and inflammations
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Interviews:
Parents and children are invited to participate in the interview, which lasts
about 25 minutes. The main topics discussed are school participation and
neurocognitive functioning.
In vitro analysis:
A side from the routine virologic, immunologic and additional measurements, we
want to draw 2 additional tubes. The following parameters are assessed:
* tissue factor expression on monocytes
* Endogeneous thrombine potential (ETP)
* Fibrine 1+2
* Prothrombine time
* van Willebrand factor
* ATIII
* Protein S
* Plasmine-antiplasmine complex
* D-dimer
* Interleukin 6
* Circulating endothelial cells
MRI
MRI imaging will be performed on a 3.0 Tesla MR unit. The following structures
will be assessed: white vs grey matter, hippocampus, cortical size and presence
of focal leasions.
Cortisol in hair
Measurement of cortisol in hair is an validated technique since recently. We
will take a small amount (10-100 hairs) from the back of the scalp.
Amendment: Circulating Endothelial Cells.
Secondary outcome
not aplicable
Background summary
With the de development of combination antiretroviral therapy (cART or HAART),
the mortality and morbidity for children with HIV has decreased drastically. In
addition, the presence of neurologic and neuropsychologic complications have
decimated. However, there are still subtle cognitive disorders found in
patients with HIV. This could have consequences for school participation and
results. The cause of these disorders have only been elucidated partly and
deserve more investigation.
Study objective
1. Evaluation of neurocgnitive functioning in children with HIV in comparison
with healthy siblings using questionnaires.
2. Qualitative analysis of different determinants that play a role in school
participation in children with HIV using interviews with the children and
parents.
3. Qualitative analysis of relation between neurocognitive functioning and
school participation in children with HIV using questionnaires and interviews.
4. Evaluation of endocrine, coagulation and immune parameters in blood and
association with neurocognitive performance, MRI and cerebral spinal fluid
analysis.
Amendment; because of interesting results in the laboratory experiments
(Circulating Endothelial Cells), we would like to add a HIV-seronegative
control population. We believe it is ethically preferred to obtain samples from
a control group that has already agreed to donate blood. It is not possible to
use the data we previously obtained from healthy uninfected adults.
Study design
Children and parents will be subjected to interviews and questionnaires by drs.
van Opstal. Siblings will also be recruited since they could act as controls.
Abnormal findings will be discussed with the clinical neuropsychologist (dr. F.
van Aarsen) the pediatric infectiologist (dr. van Rossum) and nurse specialist
(ms. van der Knaap). Additional investigations (e.g. MRI or cerebral spinal
fluid tap) will only be performed after consensus has been reached. Also, in
vitro investigation will be performed with blood products (PBMC's and plasma).
All the other parameters (e.g. viral load and CD4) will be performed as
routinely planned. We will combine the sampling as much as possible so that no
additional venapunctures are required.
Amendment: control patients will be matched on age, sex and (if possible) on
ethnicity. Sample collection will take place during planned venapuncture for
the Sophia Biobank study (MEC: 2013.381). We aim to collect 14,5ml of blood
(10ml EDTA and 4,5ml Citrate)
Study burden and risks
The questionnaires will take about 25-40 minutes (it differs per age group and
if parent, patient or sibling), see protocol page 16.
We will invite the parent and patient for an interview of about 25 minutes.
Amendment: a single extra sample collection during planned venapuncture.
's Gravendijkwal 230
Rotterdam 3015CE
NL
's Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
Inclusion criteria
Patiënt population:
- Age 4 -20
- Dutch or Eglish speaking
- HIV-infection
- Currently under treatment at Sophie Children's Hospital;Siblings:
- Age 4-20
- Dutch or English sprekend
- No HIV-infection
- Currently living in one household with patient
- Living for at least 3 years with patient;Parents:
- Dutch or English speaking
- Care giver of patient for at least 3 years;Teachers
- Dutch or English speaking
- Elementary or high school teacher of patient
Exclusion criteria
Patiënt population:
- Younger than 3 years of age
- Currently end of treatment at Sophia Children's Hospital
- History of opportunistic infection of Central Nervous system
- History of schizophrenia
- History of chronic neurological disorders like epilepsy or multiple sclerosis
- Affective disorder, reasonably causing cognitive deficits ;Siblings:
- Age below 4 years or above 20 years
- Not living in one household with patient
- Living less than 3 years with patient in one household
- History of opportunistic infection of Central Nervous system
- History of schizophrenia
- History of chronic neurological disorders like epilepsy or multiple sclerosis
- Affective disorder, reasonably causing cognitive deficits ;Parents:
- Not Dutch or English speaking;Teachers:
- Not Dutch or English speaking
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL45108.078.13 |