Primary objectives are displayed here.Part 1: Establish the effect of early life cardiovascular risk factors on pre-clinical atherosclerosis in adolescents.Part 2: Identify the impact of diminished early life lung function on lung function during…
ID
Source
Brief title
Condition
- Other condition
- Lower respiratory tract disorders (excl obstruction and infection)
- Vascular disorders NEC
Synonym
Health condition
mentaal welzijn en veerkracht
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Part 1: cIMT and PWV as cardiovascular outcomes.
Part 2: lung function measurements (spirometry).
Part 3: QoL, happiness, well-being and resilience will be measured using
validated questionnaires.
Part 4: different markers of disease activity defined through questionnaires,
physical examination and markers in the blood,
depending on the chronic disorder, will be examined in the WHISTLER population.
Secondary outcome
Part 1: Carotid artery distension using ultrasound. Endothelial functioning
using flow mediated dilation. Dyslipidemia using a lipid panel including total
cholesterol, total triglycerides, apolipoprotein B (ApoB), lipoprotein a
(Lp(a)), HDL- and LDL-cholesterol and HbA1c. Inflammation
using CRP levels. Intra-abdominal and subcutaneous fat measured by ultrasound.
Part 2: Allergic sensitization patterns and specific IgE-profiling in the blood
next to reported allergies by a questionnaire.
Part 3: Biological stress marker hair cortisol.
Background summary
The present protocol contains four separate parts with different backgrounds
that together form the Wheezing Illnesses, Study
Leidsche Rijn (WHISTLER). Two of these parts will be a follow-up on the earlier
phases of the WHISTLER cohort; the third part will
extend its focus to the impact of chronic conditions on resilience and
happiness of affected children, and the fourth part will enhance
the scope of the WHISTLER population as a healthy reference group to children
with a chronic disorder.
Part 1: The relation between early childhood risk factors and later
cardiovascular health.
Since the process of atherosclerosis is known to begin in early childhood,
cardiovascular diseases become a major threat for
children*s health. The best way to assess cardiovascular health in the
pediatric population is relatively unchartered territory.
Atherogenesis initiates in the iliac arteries and abdominal aorta, and
subsequently develops in higher regions of the arterial tree.
Modifiable risk factors such as obesity, hypertension, hyperlipidemia, and
hyperglycemia accelerate atherogenesis in the young.
Multisite and multimodal assessment of early atherosclerosis is encouraged to
capture the complexity of atherosclerosis as a
systemic disease. Next to conventional carotid intima-media thickness
measurements, implementation of aortic pulse wave velocity
measurements and flow mediated dilation can advance the assessment of early
atherosclerosis in pediatrics.
Part 2: The impact of diminished early life lung function on the development of
asthma.
Wheezing respiratory illnesses represent the most common cause of morbidity and
mortality in infancy and childhood. From the age
of about 4 years 10 - 15% of children present with wheezing due to atopic
asthma. It has been suggested that abnormal early life
lung function is associated with wheezing during later life. However, data are
scarce and results conflicting. The WHISTLER study
measured neonatal lung function of almost 2500 babies at young age and in a
subset of these children (N=1000) lung function
measurements are repeated at age 5 and 8 years. Within this follow-up part we
can further study the association between abnormal
early life lung function and the development of wheezing and asthma during
adolescence. Since atopic individuals are often
sensitive to multiple allergens (e.g. food or inhalant allergens) it would be
interesting to identify the allergic sensitization patterns in
atopic individuals and the possible differences with non-atopic individuals in
childhood and adolescence and evaluate these
sensitization patterns over time.
Part 3: The impact of chronic conditions on resilience and happiness of
affected children in adolescence age.
Over years healthcare has improved significantly with the result that earlier
defined life-threatening diseases are more often
controlled or stabilized. Consequently, the prevalence of chronic diseases,
such as asthma increased. It is known that one out of four
children grows up with a chronic disease. Having a chronic disease during
childhood influences daily and future life. Evaluating
resilience in affected children, which is defined as maintaining or regaining
mental health after exposure to severe psychological or
physical stress, would therefore be of great value.
Part 4: The WHISTLER population as a reference group for children with a
chronic disorder.
A unique added value of WHISTLER is the possibility to compare outcomes of
children with various chronic conditions (e.g.,
metabolic, endocrine disorders) followed up in the Wilhelmina Children*s
Hospital (WKZ) with healthy peers from the general
population. These collaborations make it possible to distinguish
disease-related symptoms from healthy phenomena, which could
have important implications for the child, parents and treating physician.
Study objective
Primary objectives are displayed here.
Part 1: Establish the effect of early life cardiovascular risk factors on
pre-clinical atherosclerosis in adolescents.
Part 2: Identify the impact of diminished early life lung function on lung
function during adolescence and investigate the development
of asthma.
Part 3: Determine the impact of various determinants of health (e.g. chronic
diseases, socio-economic status, sleep,) on QoL,
happiness, and resilience in adolescents.
Part 4: Distinguish disease-related symptoms from healthy phenomena in children
with various chronic conditions using the
WHISTLER population as a healthy reference group.
Study design
The WHISTLER study is a birth cohort study. The present study contains a follow
up measurement of the WHISTLER study at the age of approximately 12-18 years.
Study burden and risks
Nature and extent of the burden and risks associated with participation:
The burden and associated risks with participation are low. Of all measurements
performed in this study, only the venipuncture is an
invasive procedure with low associated risks. This follow-up will consist of
one visit to the WKZ (1,5 to 2 h) and a questionnaire filled in at
home (1 h).
Benefit associated with participation:
There is no individual benefit for the children and adolescents participating
in this study. Participation will be completely voluntary.
They will receive a ¤20,00 VVV gift voucher as a thank you for participating,
after completing the online questionnaire. Furthermore, parking costs will be
reimbursed.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
Children who reached the age of 12-18 years and who already participated in the
WHISTLER-0 and/or WHISTLER/Cardio and/or WHISTLER/Cardio2 study, and who's
parents and child are willing to give informed consent to participate in this
study. From age 16, informed consent will be obtained from the adolescent only.
Children and adolescents aged 12-18 years who already participated in the
WHISTLER round aged 12-16 years consisting of only online questionnaires,
because of the corona epidemic, will be included. This group, which consists of
around 300 children, will be approached for this new WHISTLER/ Adolescent round
since it consists of new physical measurements and an amended online
questionnaire.
Exclusion criteria
There are no exclusion criteria.
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 | NL66918.041.18 |