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NCT00016497 · ClinicalTrials.gov registry record · Phase 3
Adenoidectomy for Otitis Media in 2-3 Year Old Children
A Phase 3 study, sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD).
- Terminated
- Registry status
- Phase 3
- Development phase
NCT00016497: Clinical Trial Phase 3 study, sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD).
NCT00016497 is a Phase 3 study that was terminated before completion, run by National Institute on Deafness and Other Communication Disorders (NIDCD). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00016497, a Phase 3 study, was terminated before completion, sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD).
- TERMINATED
- Registry status
- Phase 3
- Development phase
Study Summary
The purpose of this study is to evaluate the efficacy of three different surgical treatments (1. Bilateral myringotomy and tube insertion (M\&T); 2. Adenoidectomy and bilateral myringotomy (A\&T); 3. Adenoidectomy with myringotomy and tympanostomy tube insertion (A-M\&T)) in reducing subsequent episodes of middle ear disease and hearing loss caused by the fluid in the middle ear in children aged 24-47 months. The fluid in the middle ear is of at least three months' duration and unresponsive to standardized, recent antimicrobial treatment. The children are assigned to one of the three surgical treatments. After surgery, they are followed with examinations monthly and at the time of intercurrent infections for three years.
Interventions
- PROCEDURE bilateral myringotomy
- PROCEDURE bilateral myringotomy and tubes
- PROCEDURE adenoidectomy
Trial Details
| Field | Value |
|---|---|
| Start Date | 1997-02 |
| Est. Completion | 2007-01 |
| Phase | Phase 3 |
Why NCT00016497 stopped before completion
NCT00016497 is an interventional study that assigns participants to a tested intervention. An enrollment target was not published in the registry record, which is common for early-stage or observational entries.
The record links to 0 conditions, and to 3 interventions - of which bilateral myringotomy is the first listed.
NCT00016497 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00016497 about?
NCT00016497 is a clinical study titled "Adenoidectomy for Otitis Media in 2-3 Year Old Children". The purpose of this study is to evaluate the efficacy of three different surgical treatments (1. Bilateral myringotomy and tube insertion (M\&T); 2. Adenoidectomy and bilateral myringotomy (A\&T); 3. Adenoidectomy with myringotomy and tympanostomy tube insertion (A-M\&T)) in reducing subsequent epis...
What is the current status of trial NCT00016497?
This trial is currently terminated. It is a Phase 3 study. The study started on 1997-02. Estimated completion is 2007-01.
What interventions are being tested in trial NCT00016497?
The interventions under investigation include: bilateral myringotomy (PROCEDURE), bilateral myringotomy and tubes (PROCEDURE), adenoidectomy (PROCEDURE).
Who is sponsoring clinical trial NCT00016497?
This trial is sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD), which has 34 total clinical trials registered on ClinicalTrials.gov.
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