Severe Pneumonia In Children (S-PIC) Study: A Comparative Effectiveness Study Of Children With Severe Pneumonia In Asia
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Observational

Summary: 
      Severe pneumonia is a leading cause of mortality and morbidity in children worldwide.
      Mortality rates from pediatric severe pneumonia are three times higher in South East Asia
      compared to the Western hemisphere. The lack of description of epidemiology, current
      management strategies and outcomes of children with severe pneumonia admitted to pediatric
      intensive care units (PICUs) in Asia is a barrier to improving pediatric critical care in the
      region. The lack of a sustainable pediatric critical care network in Asia makes multinational
      PICU studies challenging.

      Through the Pediatric Acute & Critical Care Medicine Asian Network (PACCMAN), the
      investigators aim to estimate the burden of pediatric patients admitted to Asian PACCMAN
      PICUs due to severe pneumonia that develop pediatric acute respiratory distress syndrome. The
      investigators will characterize etiologies, identify risk factors associated with morbidity
      and mortality, and develop prognostic prediction models. The investigators hypothesize that
      there are non-modifiable (e.g., etiological agents) and modifiable risk factors (e.g.,
      steroid therapy and ventilator strategies) that are associated with poor clinical outcomes.

      To achieve these aims, the investigators propose a prospective multicenter cohort study over
      24 months to recruit 2000 children with severe pneumonia. Pertinent demographic, clinical,
      microbiological, critical care support and management data will be collected to enable an
      investigation of the association between risk factors and clinical outcomes in these
      children. Upon completion of this large observational study, the investigators will have a
      rich database with detailed information on epidemiology, management strategies and clinical
      outcomes for severe pneumonia in Asian children.
    

Detailed description: 
      The Pediatric Acute & Critical Care Medicine Asian Network (PACCMAN) is the first pediatric
      critical care network in Asia. Through this network and this study, the investigators aim to
      provide a comprehensive epidemiological description, clinical management and outcomes of
      critically ill children with severe pneumonia across multiple sites in Asia. Through PACCMAN,
      the investigators aim to collect clinical data across at least 10 countries on children
      admitted to PICUs for severe pneumonia. Detailed data on aetiologies (not limited to
      vaccine-preventable pneumonia), broad age groups (not limited to a specific age group of
      children), and specific and supportive therapies in the PICU, will allow the investigators to
      perform comparative analysis of important non-modifiable and modifiable risk factors
      associated with mortality and functional outcomes in a large cohort of children with severe
      pneumonia. This sets the stage for multi-center studies to investigate the effectiveness of
      intensive care therapies on the outcomes of children with severe pneumonia.

      The overall aim is to study the epidemiology of severe pneumonia is Asian children and
      compare the effectiveness of currently employed management strategies (related to invasive
      mechanical ventilation, adjunct and metabolic support) on clinical outcomes in approximately
      2000 children with severe pneumonia admitted to PICUs across at least 10 countries in Asia.

      The specific aims of this study are as follows:

      Primary Aim: To (1) estimate the percentage of pediatric patients admitted to PACCMAN PICUs
      due to severe pneumonia; (2) estimate the percentage of pediatric patients admitted to PICUs
      for severe pneumonia that develop pediatric acute respiratory distress syndrome (PARDS) prior
      to PICU discharge or transfer; (3) estimate the overall and PARDS-specific mortality rates
      for children admitted for severe pneumonia; (4) characterize/classify etiologies of severe
      pneumonia according to the WHO criteria.

      Secondary Aim 1: Obtain distributions and estimates of 28-day ventilation free days and
      28-day PICU free days; estimate the proportion of patients requiring extracorporeal membrane
      oxygenation.

      Secondary Aim 2: Identify risk factors associated with morbidity and mortality rates in
      children with severe pneumonia in Asia.
    

Intervention name(s): Data collection
Intervention type(s): Other
Intervention description(s): Demographic, clinical, microbiological, critical care support and management data will be collected.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All PICU admission will be screened daily and those who meet the inclusion criteria will be
        recruited and consented (if necessary). The investigators will include all patients who are
        admitted to the PICU including those with oxygen therapy, non-invasive ventilation and
        invasive mechanical ventilation.
      
Keywords: severe pneumonia