跳至主要内容
临床试验/NCT03556488
NCT03556488招募中不适用

Prognostic Role of Ultrasonographic Air Bronchogram in the Management of Community Acquired Pneumoniae in Children

Catholic University of the Sacred Heart2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年5月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Rate of uncomplicated CAP

研究概览

简要总结

This study evaluates the prognostic role of the change of arborescent air bronchogram, a typical ultrasonographic finding of lung consolidation due to pneumonia, in the management of pediatric CAP.

详细描述

This is a single-center prospective study to evaluate the prognostic role of the change of arborescent air bronchogram, a typical ultrasonographic finding of lung consolidation due to pneumonia, in the management of CAP in terms of: 1) impact on rate of uncomplicated respiratory infections [rate of uncomplicated CAP], 2) relationship to the time of resolution of clinical signs [time to resolution of fever], 3) change of antibiotic therapy not guided by microbiological examinations and, 4) length of hospitalization.

At admission, the Pediatric will evaluate clinical signs of respiratory distress, request microbiologic tests (nasopharyngeal swab specimens and pneumococcal urinary antigen) to detect causative pathogens of CAP, and laboratory tests (complete blood cell count, acute-phase reactants C-reactive protein). Finally, all children will undergo chest radiography (CXR). If CXR should be performed before the admission to Pediatric Unit, the radiological exam will be not repeated.

Ultrasonographic evaluation will be performed by Pulmonologists. The first examination will be performed within 12 hours from admission. The Pulmonologists will be blind to clinical and radiological data.

In order to characterize the lung consolidation, a grading system based on the presence and the features of air bronchogram [static, dynamic, dynamic with areas of lung recruitment] will be adopted. The operator will collect and store images and videos (10seconds), these findings will be reviewed by an expert Clinician in chest US blind to other data.

After 48h from the admission, all children will undergo follow-up laboratory tests and lung US.

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 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Suspected CAP
  • Age from 1 to 16 years old
  • Admission to Pediatric Unit
  • Radiographic evidence of lung consolidation
  • Written informed consent from parents

排除标准

  • Gestational age < 36 weeks
  • Previous diagnosis of cystic fibrosis
  • Congenital pulmonary disease.
  • Refusal to participate.

结局指标

主要结局

Rate of uncomplicated CAP

时间窗: 48 hours

Impact on rate of uncomplicated respiratory infections

Time to resolution of fever

时间窗: Through study completion, an average of 7 days.

Relationship to the time of resolution of clinical signs

Change of antibiotic therapy

时间窗: 48 hours

Change of antibiotic therapy not guided by microbiological examinations

Length of hospitalization

时间窗: Through study completion, an average of 10 days.

Length of hospitalization

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Riccardo Inchingolo

Physician and clinical researcher

Catholic University of the Sacred Heart

研究点 (2)

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