Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Hillel Yaffe Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01157910
First received: July 4, 2010
Last updated: July 6, 2010
Last verified: July 2010
  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

Ages Eligible for Study:   1 Year to 15 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157910

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

No publications provided

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
Study First Received: July 4, 2010
Last Updated: July 6, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Hillel Yaffe Medical Center:
Ear infection
Chronic

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

ClinicalTrials.gov processed this record on November 20, 2014