Clinical trial NCT02564731: Prognosis of Bronchiectasis in Children--A Multicenter Prospective Cohort Study
Official title: Prognosis of Bronchiectasis in Children--A Multicenter Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bronchiectasis
Keywords: children
prognosis
Lead sponsor: Beijing Children's Hospital
Sponsor class: OTHER
Collaborators: name: Wuhan women and children's health care center
name: Children's Hospital of Chongqing Medical University
name: Yuying Children's Hospital of Wenzhou Medical University
name: Changchun Children's Hospital
name: Shenzhen Children's Hospital
name: Jiangxi Province Children's Hospital
name: Shanghai Children's Medical Center
name: First Affiliated Hospital of Guangxi Medical University
name: Tianjin Children's Hospital
name: The First Affiliated Hospital of Xiamen University
name: Children's Hospital of Fudan University
name: The Affiliated Hospital Of Guizhou Medical University
name: Shanxi Provincial Maternity and Children's Hospital
First posted: 2015-10-01
Enrollment: 300
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children who was confirmed diagnosis as bronchiectasis at the certain hospitals (sponsor and collaborators)

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change from baseline in lung function on the spirometry
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Children'S Hospital
state: Beijing
Study officials:
affiliation: Beijing Children's Hospital of Capital Medical University, China
name: Kunling Shen, MD,PhD
role: STUDY_DIRECTOR
affiliation: Beijing Children's Hospital of Capital Medical University, China
name: Baoping Xu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Children's Hospital of Capital Medical University, China
name: Xiaoxia Peng, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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
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