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Status Asthmaticus on the Intensive Care Prospective - STATIC PRO

Sponsor
Erasmus Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02936778
Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other), Radboud University Medical Center (Other), Maasstad Hospital (Other), Amsterdam UMC, location VUmc (Other), UMC Utrecht (Other), University Medical Center Groningen (Other), Amphia Hospital (Other), Rijnstate Hospital (Other), Tergooi Hospital (Other), Maastricht University Medical Center (Other), Leiden University Medical Center (Other)
221
Enrollment
1
Location
32
Actual Duration (Months)
6.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    221 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Risk Factors for Intensive Care Admission of Children With Severe Acute Wheeze or Asthma (SAA)
    Actual Study Start Date :
    Aug 1, 2016
    Actual Primary Completion Date :
    Apr 1, 2019
    Actual Study Completion Date :
    Apr 1, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. Socio-economic status [Within the time of admission on the PICU/MC]

    3. 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]

    4. 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]

    5. Distribution of ADRB2-receptor polymorphisms compared to non-SAA population. [Through study completion, preferably within the time of admission on the PICU/MC]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Erasmus MC Rotterdam Zuid-Holland Netherlands 3000WB

    Sponsors and Collaborators

    • Erasmus Medical Center
    • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    • Radboud University Medical Center
    • Maasstad Hospital
    • Amsterdam UMC, location VUmc
    • UMC Utrecht
    • University Medical Center Groningen
    • Amphia Hospital
    • Rijnstate Hospital
    • Tergooi Hospital
    • Maastricht University Medical Center
    • Leiden University Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Matthijs de Hoog, Prof. Dr., Erasmus Medical Center
    ClinicalTrials.gov Identifier:
    NCT02936778
    Other Study ID Numbers:
    • NL52508.078.15
    First Posted:
    Oct 18, 2016
    Last Update Posted:
    May 23, 2019
    Last Verified:
    May 1, 2019
    Keywords provided by Matthijs de Hoog, Prof. Dr., Erasmus Medical Center
    Short-term medical and psychosocial functioning
    Additional relevant MeSH terms:
    Asthma
    Status Asthmaticus

    Study Results

    No Results Posted as of May 23, 2019