Skip to main content
Clinical Trials/NCT02936778
NCT02936778
Completed
Not Applicable

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

Erasmus Medical Center1 site in 1 country221 target enrollmentAugust 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Childhood Asthma With Status Asthmaticus
Sponsor
Erasmus Medical Center
Enrollment
221
Locations
1
Primary Endpoint
Undertreatment in children admitted to a PICU with a diagnosis of SAA/acute wheeze
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
April 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Matthijs de Hoog

Prof. Dr.

Erasmus Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Exposure to triggers (single or combined)(Within the time of admission on the PICU/MC, preferably within 24 hours)
  • 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)

Study Sites (1)

Loading locations...

Similar Trials