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Clinical Trials/NCT05744609
NCT05744609
Completed
Not Applicable

Development and Validation of a Risk Score for Predicting Severe Outcomes Among Children Hospitalized With Community-acquired Pneumonia

Children's Hospital of Fudan University1 site in 1 country6,000 target enrollmentJanuary 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pneumonia
Sponsor
Children's Hospital of Fudan University
Enrollment
6000
Locations
1
Primary Endpoint
in-hospital mortality
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

In this study, investigators aimed to develop and validate a risk score to predict severe outcomes (e.g., mortality and ICU admission) in children who were admitted to the Children's Hospital of Fudan University between 2017 and 2022 due to community-acquired pneumonia (CAP). The objectives were as follows.

  1. Develop a risk prediction model based on demographic, comorbidity, clinical characteristics, laboratory data, and chest radiographic reports to predict severe outcomes among children hospitalized with CAP;
  2. Develop a risk scoring system and determine the cut-off point;
  3. Externally validate the easy-to-use risk score.
Registry
clinicaltrials.gov
Start Date
January 1, 2017
End Date
December 31, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Aged between 29 days and 18 years old;
  • Admitted to hospital with signs or symptoms of acute infection (eg, fever) and acute respiratory illness (eg, cough), and radiographic evidence of pneumonia.

Exclusion Criteria

  • Pneumonia developed 48 hours after admission or intubation;
  • Chronic pneumonia, tuberculosis, tracheobronchial foreign bodies, aspiration pneumonia, parasitic lung disease, and diffuse pulmonary interstitial/parenchyma disease.

Outcomes

Primary Outcomes

in-hospital mortality

Time Frame: from admission to discharge, an average of 7 days

in-hospital mortality among children hospitalized with CAP

Secondary Outcomes

  • admission to ICU(from admission to discharge, an average of 7 days)
  • septic shock(from admission to discharge, an average of 7 days)
  • treatment for severe pneumonia(from admission to discharge, an average of 7 days)

Study Sites (1)

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