- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02936778
Status Asthmaticus on the Intensive Care Prospective - STATIC PRO
May 21, 2019 updated by: Matthijs de Hoog, Erasmus Medical Center
Risk Factors for Intensive Care Admission of Children With Severe Acute Wheeze or Asthma (SAA)
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
221
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Zuid-Holland
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Rotterdam, Zuid-Holland, Netherlands, 3000WB
- Erasmus MC
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Children aged 2-18 years admitted to a Medium Care or Paediatric Intensive Care Unit in the Netherlands, with a diagnosis of acute wheeze or SAA.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Within the time of admission on the PICU/MC, preferably within 48 hours and during follow up after 3-6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exposure to triggers (single or combined)
Time Frame: 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
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Within the time of admission on the PICU/MC, preferably within 24 hours
|
Socio-economic status
Time Frame: Within the time of admission on the PICU/MC
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Within the time of admission on the PICU/MC
|
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Frequency of previous asthma-related hospital admissions and/or PICU admissions.
Time Frame: Within the time of admission on the PICU/MC and during follow up after 3-6 months
|
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.
Time Frame: Within the time of admission on the PICU/MC, preferably within 48 hours and during follow up after 3-6 months
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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.
Time Frame: Through study completion, preferably within the time of admission on the PICU/MC
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Through study completion, preferably within the time of admission on the PICU/MC
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2016
Primary Completion (Actual)
April 1, 2019
Study Completion (Actual)
April 1, 2019
Study Registration Dates
First Submitted
October 12, 2016
First Submitted That Met QC Criteria
October 14, 2016
First Posted (Estimate)
October 18, 2016
Study Record Updates
Last Update Posted (Actual)
May 23, 2019
Last Update Submitted That Met QC Criteria
May 21, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL52508.078.15
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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