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NCT Number: NCT04265287

Severe Pneumonia In Children (S-PIC) Study: A Comparative Effectiveness Study Of Children With Severe Pneumonia In Asia

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.

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Key information

Conditions

Pneumonia Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

KK Women and Children Hospital

Singapore

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children < 18 years old.
  • Admitted to one of the PICUs in the collaborative network.
  • Evidence of acute infection as defined as reported fever, documented fever or hypothermia, leukocytosis or leucopenia.
  • Evidence of acute respiratory illness as defined as new cough or sputum production, chest pain, dyspnea, tachypnea, abnormal respiratory examination findings or respiratory failure.
  • Radiological evidence of pneumonia within 72 hours before or after admission.

Exclusion criteria

  • Children with active do-not-resuscitate (DNR) orders
  • Children that have already been enrolled in this study within the previous 28 days
  • Have an alternative diagnosis of a respiratory disorder

Treatment and study plan

Data Collection

Other

Demographic, clinical, microbiological, critical care support and management data will be collected.

Primary outcomes

  1. Percentage of pediatric patients admitted to PACCMAN PICUs due to severe pneumonia

    Time frame: Throughout the study, over 24 months

    Estimate the percentage of pediatric patients admitted to PACCMAN PICUs due to severe pneumonia

  2. Percentage of pediatric patients admitted to PICUs for severe pneumonia that develop pediatric acute respiratory distress syndrome (PARDS) prior to PICU discharge or transfer

    Time frame: Throughout the study, over 24 months

    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. Overall and PARDS-specific mortality rates for children admitted for severe pneumonia

    Time frame: Throughout the study, over 24 months

    Estimate the overall and PARDS-specific mortality rates for children admitted for severe pneumonia

  4. Characterize/classify etiologies of severe pneumonia in children

    Time frame: Throughout study period, over 24 months

    Incidence of viral, bacterial and fungal severe pneumonia in children based on microbiological investigations performed as per standard of care.

Secondary outcomes

  1. Obtain distributions and estimates of 28-day ventilation free days in patients with severe pneumonia.

    Time frame: Up to 28 days of mechanical ventilation

    Obtain distributions and estimates of 28-day ventilation free days.

  2. Obtain distributions and estimates of 28-day PICU free days.

    Time frame: Up to 28 days of PICU stay

    Obtain distributions and estimates of 28-day PICU free days.

  3. Estimate the proportion of patients severe pneumonia requiring extracorporeal membrane oxygenation.

    Time frame: Throughout the study period, 24 months

    Total number of patients and proportion of patients with severe pneumonia requiring extracorporeal membrane oxygenation.

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Collaborators

  • Singapore Clinical Research Institute
  • Singhealth Foundation

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 11, 2020
Registry last updated
Jan 11, 2023

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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