Status Asthmaticus on the Intensive Care Prospective - STATIC PRO

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02936778

Enrollment

221

Registered

2016-10-18

Start date

2016-08-31

Completion date

2019-04-30

Last updated

2019-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Asthma With Status Asthmaticus

Keywords

Short-term medical and psychosocial functioning

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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	—

Countries

Netherlands

Outcome results