Development and Validation of an Early Prediction Model for Severe Mycoplasma Pneumoniae Pneumonia in Children

January 9, 2026 updated by: Beijing Friendship Hospital
Pneumonia is a major threat to the health of children. Mycoplasma pneumoniae infection is a core cause of pediatric pneumonia, and the incidence of severe mycoplasma pneumoniae pneumonia (SMPP) has increased in recent years. SMPP leads to a range of extrapulmonary symptoms, including myocardial and liver injury, which may be life-threatening. Therefore, there is an urgent need to establish an early warning model for SMPP to improve the prognosis of pediatric pneumonia. This observational study aims to establish a early prediction model of SMPP. Development cohorts are enrolled from Beijing Friendship Hospital between 2018-1-1 to 2024-5-31, and validation cohorts are enrolled between 2024-6-1 to 2025-6-30.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

964

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
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100050
        • Beijing Friendship Hospital

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

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children hospitalized at Beijing Friendship Hospital between 2018-01-01 and 2024-06-01, diagnosed with MPP, and with a hospital stay > 3 days (aged 1 month to 14 years) were enrolled. According to disease severity, they were divided into the mild MPP (MPP group) and severe MPP (SMPP group).

Description

Inclusion Criteria:

  • Age between 1 month to 14 years
  • diagnosed with Mycoplasma pneumoniae pneumonia
  • hospital stay ≥ 72 hours

Exclusion Criteria:

  • pulmonary chronicles
  • cardiovascular conditions
  • inherited metabolic disorders
  • immuno-deficiency disorders
  • coinfection with pathogens other than Mycoplasma pneumoniae

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
Development
A primary cohort of eligible patients from the Beijing Friendship Hospital between 2018-1-1 and 2024-5-31 is used for model derivation.
Other: medical history taking, blood test, pulmonary ultrasound
medical history taking, blood test, pulmonary ultrasound are used for MPP and SMPP diagnosis
Internal cross-validation
A cohort of consecutive patients from the Beijing Friendship Hospital between 2018-1-1 and 2024-5-31 is used for internal cross-validation.
Other: medical history taking, blood test, pulmonary ultrasound
medical history taking, blood test, pulmonary ultrasound are used for MPP and SMPP diagnosis
External validation
A cohort of patients from the Beijing Friendship Hospital between 2024-6-1 and 2025-6-30 is used for internal cross-validation.
Other: medical history taking, blood test, pulmonary ultrasound
medical history taking, blood test, pulmonary ultrasound are used for MPP and SMPP diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the curve (AUC)
Time Frame: through the hospitalization, an average of 7 days
The AUC of prediction model for SMPP
through the hospitalization, an average of 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: through the hospitalization, an average of 7 days
The sensitivity of prediction model for SMPP
through the hospitalization, an average of 7 days
Specificity
Time Frame: through the hospitalization, an average of 7 days
Specificity of prediction model for SMPP
through the hospitalization, an average of 7 days
Positive prediction value (PPV)
Time Frame: through the hospitalization, an average of 7 days
Positive prediction value (PPV) of prediction model for SMPP
through the hospitalization, an average of 7 days
Negative prediction value (NPV)
Time Frame: through the hospitalization, an average of 7 days
Negative prediction value (NPV) of prediction model for SMPP
through the hospitalization, an average of 7 days

Collaborators and Investigators

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

Sponsor

Beijing Friendship Hospital

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, 2018

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

June 30, 2025

Study Registration Dates

First Submitted

December 22, 2025

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V120250926

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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