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Clinical Characteristic of Recurrent Acute Rhinosinusitis in Children

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ClinicalTrials.gov Identifier: NCT01827176
Recruitment Status : Completed
First Posted : April 9, 2013
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
JITTIMA VESKITKUL, Mahidol University

Tracking Information
First Submitted Date March 25, 2013
First Posted Date April 9, 2013
Last Update Posted Date March 22, 2017
Study Start Date March 2013
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 4, 2013)
Presenting symptoms of recurrent acute rhinosinusitis [ Time Frame: 12 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 4, 2013)
Age of onset [ Time Frame: 12 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 8, 2013)
  • Number of sinusitis after received treatment [ Time Frame: 12 months ]
  • Immunological profile [ Time Frame: 12 months ]
    immunoglobulin level and immunoglobulin G subclass level
  • Number of participants with allergic rhinitis [ Time Frame: 12 months ]
  • Number of participants with immunodeficiency [ Time Frame: 12 months ]
  • Number of participants with adenotonsillar hypertrophy [ Time Frame: 12 months ]
Original Other Pre-specified Outcome Measures
 (submitted: April 4, 2013)
  • Treatment [ Time Frame: 12 months ]
  • Immunological profile [ Time Frame: 12 months ]
    immunoglobulin level and immunoglobulin G subclass level
  • Predisposing factors [ Time Frame: 12 months ]
    Predisposing factors such as allergic rhinitis, asthma, adenoid hypertrophy, immunodeficiency
 
Descriptive Information
Brief Title Clinical Characteristic of Recurrent Acute Rhinosinusitis in Children
Official Title Clinical Characteristic of Recurrent Acute Rhinosinusitis in Children
Brief Summary The purpose of this study is to determine the clinical characteristic of recurrent acute rhinosinusitis in children.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The patients from pediatric allergy clinic will be selected.
Condition Acute Recurrent Sinusitis
Intervention Other: Recurrent Acute Rhinosinusitis
Clinical Characteristic of Recurrent Acute Rhinosinusitis
Study Groups/Cohorts Recurrent Acute Rhinosinusitis
Recurrent Acute Rhinosinusitis is defined as acute rhinosinusitis more than 3 times/6 months or more than 4 times/year
Intervention: Other: Recurrent Acute Rhinosinusitis
Publications * Veskitkul J, Vichyanond P, Pacharn P, Visitsunthorn N, Jirapongsananuruk O. Clinical characteristics of recurrent acute rhinosinusitis in children. Asian Pac J Allergy Immunol. 2015 Dec;33(4):276-80. doi: 10.12932/AP0591.33.4.2015.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 8, 2014)
94
Original Estimated Enrollment
 (submitted: April 4, 2013)
85
Actual Study Completion Date September 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Children the age less than 15 years with recurrent acute rhinosinusitis who are attending the pediatric allergy clinic during Jan 2010 - Dec 2012.

Exclusion Criteria:

  • Children who had lost medical record.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 15 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Thailand
Removed Location Countries  
 
Administrative Information
NCT Number NCT01827176
Other Study ID Numbers 094/2556(EC4)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party JITTIMA VESKITKUL, Mahidol University
Study Sponsor Mahidol University
Collaborators Not Provided
Investigators
Principal Investigator: Jittima Veskitkul, MD Mahidol University
PRS Account Mahidol University
Verification Date March 2017