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Completed

NCT Number: NCT05744609

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.

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Key information

Conditions

Pneumonia Child Infections Lung Diseases Prognosis Respiratory Tract Diseases Respiratory Tract Infections

Age range

29 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

exposures of interest: epidemiological data, clinical characteristics, laboratory data, and chest radiographic reports

Other

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)

Primary outcomes

  1. in-hospital mortality

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

    in-hospital mortality among children hospitalized with CAP

Secondary outcomes

  1. admission to ICU

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

    admission to a intensive care unit for over 24 hours

  2. septic shock

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

    occurrence of septic shock during admission

  3. 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

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Feb 27, 2023
Registry last updated
Feb 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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