Prognosis of Bronchiectasis in Children--A Multicenter Prospective Cohort Study

January 5, 2017 updated by: Baoping XU
This prospective cohort study is designed to observe of the effect of intervention therapy on the long-term prognosis of children with bronchiectasis. The main purpose of the study was to evaluate the degree of deterioration of lung function, to observe and compare the quality of life, the time of pulmonary exacerbation, and the changes of lung image.

Study Overview

Status

Unknown

Conditions

Detailed Description

All enrolled patients are followed up for half a year, 1 years, 2 years, 3 years, 4 years, 5 years, while observation of pulmonary function, symptoms, signs, quality of life, the times of acute pulmonary exacerbation, and the changes of lung image are performed.

Study Type

Observational

Enrollment (Anticipated)

300

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
      • Beijing, Beijing, China, 100045
        • Recruiting
        • Beijing Children's 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

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children who was confirmed diagnosis as bronchiectasis at the certain hospitals (sponsor and collaborators)

Description

Inclusion Criteria:A included patient must be coincident at least one point of the four items of high-resolution computed tomography (HRCT) manifestations.

  • Internal bronchial diameter greater than the accompanying pulmonary artery.
  • lack of bronchial tapering
  • bronchi visible in the peripheral 1cm of lung
  • bronchial diameter greater than adjacent segmental bronchi

Exclusion Criteria:Subject will be excluded if she or he has one of the following

  • It is unable or doesn't agree to accept the follow-up process
  • undergoing trial for other medications or instruments.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in lung function on the spirometry
Time Frame: 5 years
forced expiratory volume at one second (FEV1) in Liter
5 years

Collaborators and Investigators

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

Sponsor

Baoping XU

Collaborators

Children's Hospital of Fudan University
Shanghai Children's Medical Center
The Affiliated Hospital Of Guizhou Medical University
Jiangxi Province Children's Hospital
Yuying Children's Hospital of Wenzhou Medical University
Shenzhen Children's Hospital
The First Affiliated Hospital of Xiamen University
Children's Hospital of Chongqing Medical University
First Affiliated Hospital of Guangxi Medical University
Shanxi Provincial Maternity and Children's Hospital
Tianjin Children's Hospital
Changchun Children's Hospital
Wuhan women and children's health care center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2016

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

September 14, 2015

First Submitted That Met QC Criteria

September 29, 2015

First Posted (Estimate)

October 1, 2015

Study Record Updates

Last Update Posted (Estimate)

January 9, 2017

Last Update Submitted That Met QC Criteria

January 5, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCHlung003

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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