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

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ClinicalTrials.gov Identifier: NCT02564731
Recruitment Status : Recruiting
First Posted : October 1, 2015
Last Update Posted : January 9, 2017
Sponsor:
Collaborators:
Wuhan women and children's health care center
Children's Hospital of Chongqing Medical University
Yuying Children's Hospital of Wenzhou Medical University
Changchun Children's Hospital
Shenzhen Children's Hospital
Jiangxi Province Children's Hospital
Shanghai Children's Medical Center
First Affiliated Hospital of Guangxi Medical University
Tianjin Children's Hospital
The First Affiliated Hospital of Xiamen University
Children's Hospital of Fudan University
The Affiliated Hospital Of Guizhou Medical University
Shanxi Provincial Maternity and Children's Hospital
Information provided by (Responsible Party):
Baoping XU, Beijing Children's Hospital

Brief Summary:
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.

Condition or disease
Bronchiectasis

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognosis of Bronchiectasis in Children--A Multicenter Prospective Cohort Study
Study Start Date : June 2016
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022



Primary Outcome Measures :
  1. Change from baseline in lung function on the spirometry [ Time Frame: 5 years ]
    forced expiratory volume at one second (FEV1) in Liter



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children who was confirmed diagnosis as bronchiectasis at the certain hospitals (sponsor and collaborators)
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02564731


Contacts
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Contact: Baoping Xu, MD,PhD 861059616308 xubaopingbch@163.com

Locations
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China, Beijing
Beijing Children'S Hospital Recruiting
Beijing, Beijing, China, 100045
Contact: baoping xu         
Sponsors and Collaborators
Baoping XU
Wuhan women and children's health care center
Children's Hospital of Chongqing Medical University
Yuying Children's Hospital of Wenzhou Medical University
Changchun Children's Hospital
Shenzhen Children's Hospital
Jiangxi Province Children's Hospital
Shanghai Children's Medical Center
First Affiliated Hospital of Guangxi Medical University
Tianjin Children's Hospital
The First Affiliated Hospital of Xiamen University
Children's Hospital of Fudan University
The Affiliated Hospital Of Guizhou Medical University
Shanxi Provincial Maternity and Children's Hospital
Investigators
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Study Director: Kunling Shen, MD,PhD Beijing Children's Hospital of Capital Medical University, China
Principal Investigator: Baoping Xu, MD,PhD Beijing Children's Hospital of Capital Medical University, China
Principal Investigator: Xiaoxia Peng, MD,PhD Beijing Children's Hospital of Capital Medical University, China

Publications:
WANG Hao,XU Bao-ping,LIU Xiu-yun,HU Ying-hui,REN Yi-xin,SHEN Kun-ling. Clinical characteristics and follow-up of bronchiectasis in children. Chinese Journal of Practical Pediatrics, 2014;29 (12):936-939
CHEN Jun, DUO Li-kun, WANG Xiao-feng. Clinical analysis of 22 children with bronchiectasis. J Clin Pediatr, 2012, 30(1):51-54.

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Responsible Party: Baoping XU, Chief of Respiratory Department, Beijing Children's Hospital
ClinicalTrials.gov Identifier: NCT02564731     History of Changes
Other Study ID Numbers: BCHlung003
First Posted: October 1, 2015    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 2017

Keywords provided by Baoping XU, Beijing Children's Hospital:
children
prognosis

Additional relevant MeSH terms:
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Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases