Clinical trial NCT02555865: Aetiology of Children With Bronchiectasis in China
Official title: Aetiology of Children With Bronchiectasis in China--A Multicenter Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bronchiectasis
Keywords: etiology
children
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: The Affiliated Hospital Of Guizhou Medical University
name: Shanxi Provincial Maternity and Children's Hospital
First posted: 2015-09-22
Enrollment: 300
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children who was confirmed diagnosis as bronchiectasis at the certain hospitals (sponsor and collaborators)

Brief summary: This multicenter retrospective observation study is designed to investigate the etiology of children with bronchiectasis by review the medical records.

Detailed description: This study is divided into two parts. Part I. Retrospective review the 10 years medical records of the children with bronchiectasis from every center, and investigate the etiology of the cases by the standard diagnostic process. Part II. All new cases of bronchiectasis which was confirmed diagnosed at every center from the beginning of the study are made the investigation of the etiology by the standard diagnostic process.

Eligibility criteria: Inclusion Criteria:A included patient must be coincident at least one point of the four items of 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 to provide complete medical records or the current condition can not accept the diagnosis process
* It does not agree to participate in the test

Primary outcomes:
measure: Number of participants with differential causes of bronchiectasis by reviewing the medical records or undergoing the standard diagnostic process
timeFrame: 48 months
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:
citation: Barker AF. Bronchiectasis. N Engl J Med. 2002 May 2;346(18):1383-93. doi: 10.1056/NEJMra012519. No abstract available.
citation: Amorim A, Gracia Roldan J. Bronchiectasis: do we need aetiological investigation? Rev Port Pneumol. 2011 Jan-Feb;17(1):32-40. English, Portuguese.
citation: Gaillard EA, Carty H, Heaf D, Smyth RL. Reversible bronchial dilatation in children: comparison of serial high-resolution computer tomography scans of the lungs. Eur J Radiol. 2003 Sep;47(3):215-20. doi: 10.1016/s0720-048x(02)00122-5.
citation: Eastham KM, Fall AJ, Mitchell L, Spencer DA. The need to redefine non-cystic fibrosis bronchiectasis in childhood. Thorax. 2004 Apr;59(4):324-7. doi: 10.1136/thx.2003.011577.
citation: Brower KS, Del Vecchio MT, Aronoff SC. The etiologies of non-CF bronchiectasis in childhood: a systematic review of 989 subjects. BMC Pediatr. 2014 Dec 10;14:4. doi: 10.1186/s12887-014-0299-y.
citation: LIU Xiu-yun, JIANG Zai-fang. The etiology of ninety-one children with bronchiecatsis. J Clin Pediatr, 2011, 29(2):127-129.
citation: CHEN Jun, DUO Li-kun, WANG Xiao-feng. Clinical analysis of 22 children with bronchiectasis. J Clin Pediatr, 2012, 30(1):51-54.
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.