Status Asthmaticus on the Intensive Care Prospective - STATIC PRO

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: Childhood Asthma With Status Asthmaticus

• Study Type: Observational
• Enrollment (Actual): 221

Contacts and Locations

Study Locations

• Netherlands
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3000WB
      • Erasmus MC

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exposure to triggers (single or combined)	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	Within the time of admission on the PICU/MC, preferably within 24 hours
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
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

Collaborators and Investigators

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

Study record dates

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

• Keywords: Short-term medical and psychosocial functioning
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Status Asthmaticus
• Other Study ID Numbers: NL52508.078.15