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Clinical Characteristic of Recurrent Acute Rhinosinusitis in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01827176
First Posted: April 9, 2013
Last Update Posted: March 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
JITTIMA VESKITKUL, Mahidol University
  Purpose
The purpose of this study is to determine the clinical characteristic of recurrent acute rhinosinusitis in children.

Condition Intervention
Acute Recurrent Sinusitis Other: Recurrent Acute Rhinosinusitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Clinical Characteristic of Recurrent Acute Rhinosinusitis in Children

Further study details as provided by JITTIMA VESKITKUL, Mahidol University:

Primary Outcome Measures:
  • Presenting symptoms of recurrent acute rhinosinusitis [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Age of onset [ Time Frame: 12 months ]

Other Outcome Measures:
  • 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 ]

Enrollment: 94
Study Start Date: March 2013
Study Completion Date: September 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Recurrent Acute Rhinosinusitis
Recurrent Acute Rhinosinusitis is defined as acute rhinosinusitis more than 3 times/6 months or more than 4 times/year
Other: Recurrent Acute Rhinosinusitis
Clinical Characteristic of Recurrent Acute Rhinosinusitis

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patients from pediatric allergy clinic will be selected.
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.
  Contacts and Locations
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): NCT01827176


Locations
Thailand
Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Jittima Veskitkul, MD Mahidol University
  More Information

Publications:
Responsible Party: JITTIMA VESKITKUL, Dr., Mahidol University
ClinicalTrials.gov Identifier: NCT01827176     History of Changes
Other Study ID Numbers: 094/2556(EC4)
First Submitted: March 25, 2013
First Posted: April 9, 2013
Last Update Posted: March 22, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by JITTIMA VESKITKUL, Mahidol University:
Characteristic
Recurrent Acute Rhinosinusitis
Children

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases