Predicting Severe Outcomes Among Children Hospitalized With Community-acquired Pneumonia

Sponsor
Children's Hospital of Fudan University (Other)
Overall Status
Completed
CT.gov ID
NCT05744609
Collaborator
(none)
6,000
1
72
83.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: exposures of interest: epidemiological data, clinical characteristics, laboratory data, and chest radiographic reports

Study Design

Study Type:
Observational
Actual Enrollment :
6000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Development and Validation of a Risk Score for Predicting Severe Outcomes Among Children Hospitalized With Community-acquired Pneumonia
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Dec 31, 2022
Actual Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm 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)

Outcome Measures

Primary Outcome Measures

  1. in-hospital mortality [from admission to discharge, an average of 7 days]

    in-hospital mortality among children hospitalized with CAP

Secondary Outcome Measures

  1. admission to ICU [from admission to discharge, an average of 7 days]

    admission to a intensive care unit for over 24 hours

  2. septic shock [from admission to discharge, an average of 7 days]

    occurrence of septic shock during admission

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
29 Days to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's Hospital of Fudan University Shanghai Shanghai China 201102

Sponsors and Collaborators

  • Children's Hospital of Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Children's Hospital of Fudan University
ClinicalTrials.gov Identifier:
NCT05744609
Other Study ID Numbers:
  • 20230203
First Posted:
Feb 27, 2023
Last Update Posted:
Feb 27, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 27, 2023