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Bacterial Assessment of Middle Ear Fluid in Children Undergoing Ventilation Tube Placement Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01157910
First Posted: July 7, 2010
Last Update Posted: July 7, 2010
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:
Hillel Yaffe Medical Center
  Purpose

Children with chronic otitis media have more resistant bacteria that require surgical intervention to eradicate the infections. The study will evaluate the dominant bacteria and their sensitivities to antibiotics. The information will assist in better treatment plans for children with chronic infections.

The data will also assess the changing patterns in the bacteria colonizing middle ear fluid.


Condition
Chronic Otitis Media Age Determined Bacteria

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: An Epidemiological and Bacteriological Assessment of Middle Ear Fluid in Children Undergoing Ventilation Tube Placement Surgery

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

Estimated Enrollment: 50
Study Start Date: September 2010
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Detailed Description:
ibid.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children suffering from chronic otitis media who are scheduled for surgery.
Criteria

Inclusion Criteria:

  • All children with chronic ear infections scheduled for surgical interventions

Exclusion Criteria:

  • Children who have undergone prior mastoid surgery, or children with oncologic treatments.
  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): NCT01157910


Locations
Israel
Hillel Yaffe MC, Not yet recruiting
Hadera, Israel
Sponsors and Collaborators
Hillel Yaffe Medical Center
  More Information

Responsible Party: Dr. Shimon Schreiber, Hillel Yaffe Hospital, Department of Ear Nose And Throat
ClinicalTrials.gov Identifier: NCT01157910     History of Changes
Other Study ID Numbers: 36-2009
First Submitted: July 4, 2010
First Posted: July 7, 2010
Last Update Posted: July 7, 2010
Last Verified: July 2010

Keywords provided by Hillel Yaffe Medical Center:
Ear infection
Chronic

Additional relevant MeSH terms:
Otitis Media
Otitis
Ear Diseases
Otorhinolaryngologic Diseases