A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion

Completed · Not applicable · Has a placebo group

Conditions studied: Otitis Media With Effusion

In brief

This study is being done to see if reflux of stomach fluid might be a cause of chronic fluid in the ears. Our hypothesis is that treatment with an anti-reflux medication (lansoprazole) will increase the rate of resolution of chronic middle ear fluid in children.

Key facts

Study ID

NCT00546117

Run by

Washington University School of Medicine

People needed

16

Starts

2007-10-01

Expected to finish

2009-12-01

Last updated by the study team

2018-06-01

Who can join

Age: 2 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• History of chronic otitis media with effusion meeting clinical indications for tympanostomy tubes placement, defined as the presence of middle ear fluid on physical exam for at least 3 months, in at least one ear.

You may not qualify if…

• Past medical history or concurrent conditions known to increase the incidence of either recurrent otitis media or otitis media with effusion or gastroesophageal reflux disease, including cleft palate, neurological delay, cerebral palsy, Down syndrome, velocardiofacial syndrome, and primary ciliary dyskinesia.
• Children with structural abnormalities of the tympanic membranes, such as cholesteatoma, deep retraction pockets, and atelectasis of the tympanic membrane. These abnormalities would require placement of tympanostomy tubes in standard clinical practice.
• Children weighing less than 10 kilograms, due to the lower weight limit for standard Prevacid™ dosing

Where it is running

• St. Louis Children's Hospital — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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