OHSU

IRB #

IRB00009341

Title

“Quality of Life Outcomes in Down Syndrome after PE Tube Placement “.

Principal Investigator

Carol MacArthur

Study Purpose

To study quality of life outcome change after placement of tympanostomy tubes (ear tubes),comparing a population of Down syndrome patients to a non-syndromic population.

Medical Condition(s)

Otitis media leading to ear tube placement, eith recurrent acute otitis media or chronic otitis media

Eligibility Criteria

All patients with Down Syndrome (DS) less than or equal to 16 years of age undergoing PET placement +/- adenoidectomy will be eligible for enrollment. The exclusion criterion is any patient unwilling or unable to tolerate general anesthetic for PET placement due to comorbidities or family preference. A control group will also be recruited of otherwise healthy children less than or equal to 16 years of age receiving PE tube placement (+/- adenoidectomy) for recurrent ear infections or chronic ear infections (ear fluid, etc). Exclusion criteria for the control population will be syndromic diagnosis, cleft palate, cholesteatoma, developmental or intellectual disability, craniofacial deformity, immune deficiency, diagnosis of malignancy or prior treatment for malignancy, ciliary dyskinesia, or other medical condition leading to predilection for prolonged ear disease.

Age Range

0 - 16

Healthy Volunteers Needed

No

Duration of Participation

4 months

Minors Included

Yes

Contact

Carol MacArthur, MD
503-494-5350
macarthc@ohsu.edu

Sponsor

AAO-HNS CORE grant,application submitted. Funding would begin July 1, 2013

Recruitment End

06/30/2014

Compensation Provided

No


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