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Status Asthmaticus on the Intensive Care Prospective - STATIC PRO

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ClinicalTrials.gov Identifier: NCT02936778
Recruitment Status : Recruiting
First Posted : October 18, 2016
Last Update Posted : February 6, 2018
Sponsor:
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Radboud University
Maasstad Hospital
VU University Medical Center
UMC Utrecht
University Medical Center Groningen
Amphia Hospital
Rijnstate Hospital
Tergooi Hospital
Maastricht University Medical Center
Leiden University Medical Center
Information provided by (Responsible Party):
Matthijs de Hoog, Erasmus Medical Center

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
Childhood Asthma With Status Asthmaticus

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Study Type : Observational
Estimated Enrollment : 220 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 : August 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. Socio-economic status [ Time Frame: Within the time of admission on the PICU/MC ]
  3. 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 ]
  4. 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 ]
  5. 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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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02936778


Contacts
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Contact: Shelley Boeschoten, Drs. 0031630035001 s.boeschoten@erasmusmc.nl

Locations
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Netherlands
Erasmus MC Recruiting
Rotterdam, Zuid-Holland, Netherlands, 3000WB
Contact: Shelley A Boeschoten, Drs.    0031630035001    s.boeschoten@erasmusmc.nl   
Sponsors and Collaborators
Erasmus Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Radboud University
Maasstad Hospital
VU University Medical Center
UMC Utrecht
University Medical Center Groningen
Amphia Hospital
Rijnstate Hospital
Tergooi Hospital
Maastricht University Medical Center
Leiden University Medical Center

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Responsible Party: Matthijs de Hoog, Prof. Dr., Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT02936778     History of Changes
Other Study ID Numbers: NL52508.078.15
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018

Keywords provided by Matthijs de Hoog, Erasmus Medical Center:
Short-term medical and psychosocial functioning

Additional relevant MeSH terms:
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Asthma
Status Asthmaticus
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases