Status Asthmaticus on the Intensive Care Prospective - STATIC PRO

Completed

• Conditions: Childhood Asthma With Status Asthmaticus

• Registration Number: NCT02936778
• Lead Sponsor: Erasmus Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-10-12
• Study First Submitted QC: 2016-10-14
• Study First Posted: 2016-10-18
• Primary Completion: 2019-04
• Study Completion: 2019-04
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-21
• Last Update Posted: 2019-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 221

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Undertreatment in children admitted to a PICU with a diagnosis of SAA/acute wheeze	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.

Secondary Outcome Measures

Name	Time	Method
Exposure to triggers (single or combined)	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
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
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

Trial Locations

Locations (1)

Erasmus MC; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands