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

NCT ID: NCT07333833

Last Updated: 2026-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

964 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Mycoplasma Pneumoniae Pneumonia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

medical history taking, blood test, pulmonary ultrasound

Intervention Type OTHER

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.

medical history taking, blood test, pulmonary ultrasound

Intervention Type OTHER

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.

medical history taking, blood test, pulmonary ultrasound

Intervention Type OTHER

medical history taking, blood test, pulmonary ultrasound are used for MPP and SMPP diagnosis

Interventions

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medical history taking, blood test, pulmonary ultrasound

medical history taking, blood test, pulmonary ultrasound are used for MPP and SMPP diagnosis

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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V120250926

Identifier Type: -

Identifier Source: org_study_id

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