Clinical trial NCT02936778: Status Asthmaticus on the Intensive Care Prospective - STATIC PRO
Official title: Risk Factors for Intensive Care Admission of Children With Severe Acute Wheeze or Asthma (SAA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Asthma With Status Asthmaticus
Keywords: Short-term medical and psychosocial functioning
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Radboud University Medical Center
name: Maasstad Hospital
name: Amsterdam UMC, location VUmc
name: UMC Utrecht
name: University Medical Center Groningen
name: Amphia Hospital
name: Rijnstate Hospital
name: Tergooi Hospital
name: Maastricht University Medical Center
name: Leiden University Medical Center
First posted: 2016-10-18
Enrollment: 221
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children aged 2-18 years admitted to a Medium Care or Paediatric Intensive Care Unit in the Netherlands, with a diagnosis of acute wheeze or SAA.

Brief summary: This study will prospectively assess the impact and relevance of several risk factors for children with severe acute asthma (SAA) or acute wheeze that have been identified in retrospective studies. Secondary we will assess short-term medical and psychosocial functioning in patient (and parents) admitted to a PICU for SAA/acute wheeze versus a control group admitted to a MC for SAA/acute wheeze.


Eligibility criteria: Inclusion Criteria:

* Between 2 and 18 years of age
* Admission to a PICU for SAA or acute wheeze or admission to a MC for SAA or acute wheeze

Exclusion Criteria:

* Patient is outside of specified age range
* Down's Syndrome
* Congenital/acquired heart defect that interferes with normal SAA treatment
* Congenital/acquired airway defect (tracheomalacia/bronchomalacia)
* Primary/secondary immunodeficiency
* Pre-existing chronic pulmonary condition, known to mimic asthma: Cystic Fibrosis, Bronchopulmonary dysplasia, Bronchiolitis obliterans
* If both parents are not able to speak the Dutch language

Primary outcomes:
measure: Undertreatment in children admitted to a PICU with a diagnosis of SAA/acute wheeze
timeFrame: Within the time of admission on the PICU/MC, preferably within 48 hours and during follow up after 3-6 months
Secondary outcomes:
measure: Exposure to triggers (single or combined)
timeFrame: Within the time of admission on the PICU/MC, preferably within 24 hours
measure: Socio-economic status
timeFrame: Within the time of admission on the PICU/MC
measure: Frequency of previous asthma-related hospital admissions and/or PICU admissions.
timeFrame: Within the time of admission on the PICU/MC and during follow up after 3-6 months
measure: Severity of disease, defined using the GINA criteria for stepwise management of asthma.
timeFrame: Within the time of admission on the PICU/MC, preferably within 48 hours and during follow up after 3-6 months
measure: Distribution of ADRB2-receptor polymorphisms compared to non-SAA population.
timeFrame: Through study completion, preferably within the time of admission on the PICU/MC
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
Study officials:
References: