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

NCT04265287 | Completed

• 1 other identifier: S-PIC
• Study Type: observational
• Target: 931
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pneumonia

Keywords

severe pneumonia

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (3)

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

  Up to 28 days of mechanical ventilation

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

  Up to 28 days of PICU stay

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

  Throughout the study period, 24 months

Study Arms (1)

Pediatric patients with severe pneumonia

Pediatric patients admitted to PICU due to severe pneumonia

Other: Data collection

Interventions

Data collection OTHER

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

Pediatric patients with severe pneumonia

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead
• Singapore Clinical Research Institute: collaborator
• Singhealth Foundation: collaborator

Study Sites (1)

KK Women and Children Hospital

Singapore, Singapore

Location

Related Publications (1)

• Wong JJM, Abbas Q, Wang JQY, Xu W, Dang H, Phan PH, Guo L, Lee PC, Zhu X, Angurana SK, Pukdeetraipop M, Efar P, Yuliarto S, Choi I, Fan L, Hui AWF, Gan CS, Liu C, Samransamruajkit R, Cho HJ, Ong JSM, Lee JH; Pediatric Acute and Critical Care Asian Network (PACCMAN). Severe Pneumonia in PICU Admissions: The Pediatric Acute and Critical Care Medicine Asian Network (PACCMAN) Observational Cohort Study, 2020-2022. Pediatr Crit Care Med. 2024 Nov 1;25(11):1035-1044. doi: 10.1097/PCC.0000000000003598. Epub 2024 Aug 23.

  PMID: 39177431 DERIVED

MeSH Terms

Conditions

Pneumonia

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jan Hau Lee

  KK Women's and Children's Hospital, SingHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: February 11, 2020
• Study Start: June 8, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: January 11, 2023

Record last verified: 2023-01

Locations

SG (1)