Predicting Severe Outcomes Among Children Hospitalized With Community-acquired Pneumonia

Completed

• Conditions: Child; Pneumonia; Prognosis

• Registration Number: NCT05744609
• Lead Sponsor: Children's Hospital of Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-02
• Study First Submitted: 2023-02-06
• Study First Submitted QC: 2023-02-15
• Last Update Submitted: 2023-02-15
• Study First Posted: 2023-02-27
• Last Update Posted: 2023-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6000

Inclusion Criteria

1. Aged between 29 days and 18 years old;
2. 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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
in-hospital mortality	from admission to discharge, an average of 7 days	in-hospital mortality among children hospitalized with CAP

Secondary Outcome Measures

Name	Time	Method
admission to ICU	from admission to discharge, an average of 7 days	admission to a intensive care unit for over 24 hours
septic shock	from admission to discharge, an average of 7 days	occurrence of septic shock during admission
treatment for severe pneumonia	from admission to discharge, an average of 7 days	vasoactive agents, positive-pressure ventilation or chest drainage, or extracorporeal membrane oxygenation

Trial Locations

Locations (1)

Children's Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China