Status Asthmaticus on the Intensive Care Prospective - STATIC PRO

NCT ID: NCT02936778

Last Updated: 2019-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

221 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2019-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Childhood Asthma With Status Asthmaticus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

MC (= control group)

Children aged 2-18 years admitted to a Medium Care in the Netherlands, with a diagnosis of acute wheeze or SAA.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role collaborator

Maasstad Hospital

OTHER

Sponsor Role collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role collaborator

University Medical Center Groningen

OTHER

Sponsor Role collaborator

Amphia Hospital

OTHER

Sponsor Role collaborator

Rijnstate Hospital

OTHER

Sponsor Role collaborator

Tergooi Hospital

OTHER

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role collaborator

Leiden University Medical Center

OTHER

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Matthijs de Hoog

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Erasmus MC

Rotterdam, South Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL52508.078.15

Identifier Type: -

Identifier Source: org_study_id

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