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Completed

NCT Number: NCT02936778

Status Asthmaticus on the Intensive Care Prospective - STATIC PRO

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.

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Key information

Conditions

Childhood Asthma With Status Asthmaticus

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasmus MC

Rotterdam, South Holland, 3000WB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

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

Registry information

Official study title

Risk Factors for Intensive Care Admission of Children With Severe Acute Wheeze or Asthma (SAA)

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 18, 2016
Registry last updated
May 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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