Status Asthmaticus on the Intensive Care Prospective - STATIC PRO

Childhood Asthma With Status Asthmaticus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02936778
• Other study ID #: NL52508.078.15
• Status: Completed
• Start date: August 2016
• Est. completion date: April 2019

Study information

• Verified date: May 2019
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Childhood Asthma With Status Asthmaticus
• Status Asthmaticus

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam	Zuid-Holland

Sponsors (12)

Lead Sponsor	Collaborator
Erasmus Medical Center	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Amphia Hospital, Leiden University Medical Center, Maasstad Hospital, Maastricht University Medical Center, Radboud University, Rijnstate Hospital, Tergooi Hospital, UMC Utrecht, University Medical Center Groningen, VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Socio-economic status		Within the time of admission on the PICU/MC
Secondary	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
Secondary	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
Secondary	Distribution of ADRB2-receptor polymorphisms compared to non-SAA population.		Through study completion, preferably within the time of admission on the PICU/MC