Status Asthmaticus on the Intensive Care Prospective - STATIC PRO

Study Overview
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Brief Summary
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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.

Official Title
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Risk Factors for Intensive Care Admission of Children With Severe Acute Wheeze or Asthma (SAA)

Conditions
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Childhood Asthma With Status Asthmaticus

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PICU (= case group)<br>Children aged 2-18 years admitted to a Paediatric Intensive Care Unit in the Netherlands, with a diagnosis of acute wheeze or SAA. | |
| MC (= control group)<br>Children aged 2-18 years admitted to a Medium Care in the Netherlands, with a diagnosis of acute wheeze or SAA. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Undertreatment in children admitted to a PICU with a diagnosis of SAA/acute wheeze | Undertreatment is defined as: Patient is not using inhaled corticosteroids (ICS), or Patient is using ICS < 7 days (counting from moment of admission to emergency department) according to treatment plan, or Patient is not using ICS according tot treatment plan. | Within the time of admission on the PICU/MC, preferably within 48 hours and during follow up after 3-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exposure to triggers (single or combined) | Pollution/airborne particulate matter (PM10), sensitization/allergen exposure, cigarette smoke exposure (measured by cotinine in urine), presence and type of virus in upper airway tract | Within the time of admission on the PICU/MC, preferably within 24 hours | 
| Socio-economic status |  | Within the time of admission on the PICU/MC | 
| Frequency of previous asthma-related hospital admissions and/or PICU admissions. |  | Within the time of admission on the PICU/MC and during follow up after 3-6 months | 
| Severity of disease, defined using the GINA criteria for stepwise management of asthma. |  | Within the time of admission on the PICU/MC, preferably within 48 hours and during follow up after 3-6 months | 
| Distribution of ADRB2-receptor polymorphisms compared to non-SAA population. |  | Through study completion, preferably within the time of admission on the PICU/MC | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Short-term medical and psychosocial functioning