Status Asthmaticus on the Intensive Care Prospective - STATIC PRO

NCT02936778 | Completed

• 1 other identifier: NL52508.078.15
• Study Type: observational
• Target: 221
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Asthma With Status Asthmaticus

Keywords

Short-term medical and psychosocial functioning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Exposure to triggers (single or combined)

  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

Study Arms (2)

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.

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3000WB, Netherlands

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 18, 2016
• Study Start: August 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: May 23, 2019

Record last verified: 2019-05

Locations

NL (1)