Status Asthmaticus on the Intensive Care Prospective - STATIC PRO
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|ClinicalTrials.gov Identifier: NCT02936778|
Recruitment Status : Recruiting
First Posted : October 18, 2016
Last Update Posted : February 6, 2018
|Condition or disease|
|Childhood Asthma With Status Asthmaticus|
|Study Type :||Observational|
|Estimated Enrollment :||220 participants|
|Official Title:||Risk Factors for Intensive Care Admission of Children With Severe Acute Wheeze or Asthma (SAA)|
|Actual Study Start Date :||August 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||January 2019|
PICU (= case group)
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)
Children aged 2-18 years admitted to a Medium Care in the Netherlands, with a diagnosis of acute wheeze or SAA.
- Undertreatment in children admitted to a PICU with a diagnosis of SAA/acute wheeze [ Time Frame: Within the time of admission on the PICU/MC, preferably within 48 hours and during follow up after 3-6 months ]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.
- Exposure to triggers (single or combined) [ Time Frame: Within the time of admission on the PICU/MC, preferably within 24 hours ]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
- Socio-economic status [ Time Frame: Within the time of admission on the PICU/MC ]
- Frequency of previous asthma-related hospital admissions and/or PICU admissions. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Through study completion, preferably within the time of admission on the PICU/MC ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02936778
|Contact: Shelley Boeschoten, Drs.||firstname.lastname@example.org|
|Rotterdam, Zuid-Holland, Netherlands, 3000WB|
|Contact: Shelley A Boeschoten, Drs. 0031630035001 email@example.com|