跳至主要内容
临床试验/NCT07333833
NCT07333833已完成不适用

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

Beijing Friendship Hospital1 个研究点 分布在 1 个国家目标入组 964 人开始时间: 2018年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
964
试验地点
1
主要终点
Area under the curve (AUC)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Month 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

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.

干预措施: medical history taking, blood test, pulmonary ultrasound (Other)

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.

干预措施: medical history taking, blood test, pulmonary ultrasound (Other)

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.

干预措施: medical history taking, blood test, pulmonary ultrasound (Other)

结局指标

主要结局

Area under the curve (AUC)

时间窗: through the hospitalization, an average of 7 days

The AUC of prediction model for SMPP

次要结局

  • Sensitivity(through the hospitalization, an average of 7 days)
  • Specificity(through the hospitalization, an average of 7 days)
  • Positive prediction value (PPV)(through the hospitalization, an average of 7 days)
  • Negative prediction value (NPV)(through the hospitalization, an average of 7 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验