Pneumonia Clinical Trial
Official title:
Severe Pneumonia In Children (S-PIC) Study: A Comparative Effectiveness Study Of Children With Severe Pneumonia In Asia
NCT number | NCT04265287 |
Other study ID # | S-PIC |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 8, 2020 |
Est. completion date | September 30, 2022 |
Verified date | January 2023 |
Source | KK Women's and Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 931 |
Est. completion date | September 30, 2022 |
Est. primary completion date | September 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Day to 18 Years |
Eligibility | Inclusion Criteria: 1. Children < 18 years old. 2. Admitted to one of the PICUs in the collaborative network. 3. Evidence of acute infection as defined as reported fever, documented fever or hypothermia, leukocytosis or leucopenia. 4. Evidence of acute respiratory illness as defined as new cough or sputum production, chest pain, dyspnea, tachypnea, abnormal respiratory examination findings or respiratory failure. 5. Radiological evidence of pneumonia within 72 hours before or after admission. Exclusion Criteria: 1. Children with active do-not-resuscitate (DNR) orders 2. Children that have already been enrolled in this study within the previous 28 days 3. Have an alternative diagnosis of a respiratory disorder |
Country | Name | City | State |
---|---|---|---|
Singapore | KK Women and Children Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
KK Women's and Children's Hospital | Singapore Clinical Research Institute, Singhealth Foundation |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of pediatric patients admitted to PACCMAN PICUs due to severe pneumonia | Estimate the percentage of pediatric patients admitted to PACCMAN PICUs due to severe pneumonia | Throughout the study, over 24 months | |
Primary | Percentage of pediatric patients admitted to PICUs for severe pneumonia that develop pediatric acute respiratory distress syndrome (PARDS) prior to PICU discharge or transfer | 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 | Throughout the study, over 24 months | |
Primary | Overall and PARDS-specific mortality rates for children admitted for severe pneumonia | Estimate the overall and PARDS-specific mortality rates for children admitted for severe pneumonia | Throughout the study, over 24 months | |
Primary | Characterize/classify etiologies of severe pneumonia in children | Incidence of viral, bacterial and fungal severe pneumonia in children based on microbiological investigations performed as per standard of care. | Throughout study period, over 24 months | |
Secondary | Obtain distributions and estimates of 28-day ventilation free days in patients with severe pneumonia. | Obtain distributions and estimates of 28-day ventilation free days. | Up to 28 days of mechanical ventilation | |
Secondary | Obtain distributions and estimates of 28-day PICU free days. | Obtain distributions and estimates of 28-day PICU free days. | Up to 28 days of PICU stay | |
Secondary | Estimate the proportion of patients severe pneumonia requiring extracorporeal membrane oxygenation. | Total number of patients and proportion of patients with severe pneumonia requiring extracorporeal membrane oxygenation. | Throughout the study period, 24 months |
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