Predicting Severe Outcomes Among Children Hospitalized With Community-acquired Pneumonia

February 15, 2023 updated by: Children's Hospital of Fudan University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

6000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201102
        • Children's Hospital of Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This was a retrospective cohort study of children aged between > 29 days and 18 years old who were admitted to the Children's Hospital of Fudan University in Shanghai, China from January 1, 2017 to December 31, 2022. Children were enrolled if they were hospitalized with signs and symptoms of lower respiratory tract infection and radiographic evidence of pneumonia.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
children hospitalized with community-acquired pneumonia
Other: exposures of interest: epidemiological data, clinical characteristics, laboratory data, and chest radiographic reports
epidemiological data (e.g., age, sex, and residential area), clinical characteristics (e.g., fever, cough, and wheeze), laboratory data (e.g., white blood cell, c-reaction protein, and procalcitonin), and chest radiographic reports (e.g., X-ray, CT, and ultrasound)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
in-hospital mortality
Time Frame: from admission to discharge, an average of 7 days
in-hospital mortality among children hospitalized with CAP
from admission to discharge, an average of 7 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

February 6, 2023

First Submitted That Met QC Criteria

February 15, 2023

First Posted (Estimate)

February 27, 2023

Study Record Updates

Last Update Posted (Estimate)

February 27, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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