N/A
N=16
A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion
Otitis Media With Effusion
Bottom Line
View on ClinicalTrials.gov: NCT00546117 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jan 2011
Primary outcome: Primary: Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear — 1; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- lansoprazole (Drug); placebo (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear |
1; 0 | — |
| PRIMARY Absence of Middle Ear Fluid by Pneumatic Otoscopy, LeftEar |
1; 3 | — |
| SECONDARY Acoustic Reflectometry: Level of Risk as Defined by Manufacturer |
2.5; 3.5 | — |
| SECONDARY Number of Participants With Normal Type A Tympanometry |
0; 0 | — |
| SECONDARY Number of Participants With at Least 1 Symptoms of Reflux in the Past Week, Assessed by the Reflux Symptom Questionnaire |
0; 0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00546117). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.