Primary Objective: To prospectively assess the impact and relevance of several risk factors for SAA/acute wheeze that have been identified in retrospective studies, including our own. Secondary Objective: To assess short-term medical and…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Undertreatment, defined as:
Patient is not using inhaled corticosteroids (ICS), or
Patient is using ICS for <7 days (counting from moment of admission to
emergency department) according to treatment plan, or
Patient is not using ICS according to treatment plan.
Use of medication is estimated through obtaining pharmacy records on medication
that was picked up by the patient, versus the medication that is required
according to the treatment plan. If a patient indicates that he/she did not use
their medication correctly (despite pharmacy records indicating pickup), this
patient is counted as being "undertreated".
Secondary outcome
* Exposure to air pollution/airborne particulate matter (PM10), acute (<48h).
* Exposure to furry animals in the primary home (as reported by parents) to
which the child is sensitised.
* Exposure to house dust mite in the primary home, if the child is sensitised
(>0,1kU/L on RAST).
* Exposure to cigarette smoke, as measured by cotinine in urine.
* Type of virus in upper airway tract.
* Socio-economic status, defined by highest education of both parents and
occupation of both parents.
* Severity of asthma at follow-up, defined as *3 on GINA treatment level.
* A previous admission to a hospital (MC) for asthma.
* A previous admission to a PICU for asthma.
* Distribution of ADRB2-receptor polymorphisms, compared to the non-SAA
population.
* CBCL scores. The CBCL uses a continuous scale (interval) where a higher score
indicates more problems within a certain area of interest.
* PA(C)QLQ scores. The PAQLQ and PACQLQ use continuous scales (interval) where
a higher score indicates better quality of life.
* SVLK-k/o. The SVLK-k and *o use continuous scales (interval) where a higher
score indicates more severe PTSD.
Background summary
Most asthma guidelines offer evidence-based or best practice approaches to the
management of asthma exacerbations but struggle with the presentation of a
robust evidence-based approach for severe acute asthma exacerbations (SAA) or
acute wheeze. Retrospective research indicates that preventive measures could
be installed when the pathophysiology or *clinical phenotype* of children with
SAA/acute wheeze is better understood. In addition, this could enable more
effective treatment, leading to quicker resolution of exacerbations, with less
functional morbidity. In our retrospective multicentre case control study, 4
risk factors remained significant: active or passive smoking, allergies,
earlier hospitalisation for asthma, and non-sanitised homes. Other studies
suggest that undertreatment of asthma or specific viruses like Rhinovirus Type
C are relevant risk factors.
Study objective
Primary Objective: To prospectively assess the impact and relevance of several
risk factors for SAA/acute wheeze that have been identified in retrospective
studies, including our own.
Secondary Objective: To assess short-term medical and psychosocial functioning
in patients (and parents) admitted to a PICU for SAA/acute wheeze versus a
control group admitted to an MC for SAA/acute wheeze.
Study design
Observational, prospective comparative cohort study
Study burden and risks
The risk associated with participation is negligible, the burden minimal. Each
patient and/or his parent(s)/legal guardian will be asked to fill out several
questionnaires, regarding the disease, treatment, psychosocial functioning etc.
These questionnaires contain no items of a sensitive nature. Collection of
blood for Radio Allergo-Sorbent Test (RAST) is part of standard care in
patients with SAA. Collection of a nasal swab to determine viral infection is
not part of standard care, but poses minimal additional burden to the patient.
Collection of a urine sample for cotinine is not part of standard care, but
poses no additional burden to the patient. Collection of an additional 0.5ml of
blood to determine ADRB2-receptor polymorphisms is not part of standard care,
but poses no additional burden to the patient. All hospital visits fall within
standard care, namely the initial hospital admittance and stay, and subsequent
outpatient follow-up by a paediatrician/paediatric pulmonologist (including a
lung function test in patients older than 4 years of age).
This study can only be performed in children, as paediatric asthma and SAA
differ greatly from the same disease in adults.
Wytemaweg 80
Rotterdam 3015CN
NL
Wytemaweg 80
Rotterdam 3015CN
NL
Listed location countries
Age
Inclusion criteria
-Between 2 and 18 years of age
-Admission to a PICU for status asthmaticus or acute wheeze
-Admission to a MC for status asthmaticus or acute wheeze
Exclusion criteria
-Patient is outside of specified age range
-Patient has Down*s Syndrome
-Patient has a congenital/acquired heart defect that interferes with normal SAA treatment
-Patient has a congenital/acquired airway defect (Tracheomalacia, Bronchomalacia)
-Patient has a primary/secondary immunodeficiency
-Patient has a pre-existing chronic pulmonary condition, known to mimic asthma: Cystic fibrosis, Bronchopulmonary dysplasia, Bronchiolitis obliterans.
-Any subject who receives a different diagnosis than SAA / asthma exacerbation within the timeframe of the admission
-Any subject who does not provide informed consent or repeals informed consent (either by patient or by guardian(s)).
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 | NL52508.078.15 |