Otitis Media With EffusionPhase 3NCT00016497
Adenoidectomy for Otitis Media in 2-3 Year Old Children
A Phase 3 study testing bilateral myringotomy, bilateral myringotomy and tubes and adenoidectomy in people with Otitis Media With Effusion, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 47 months
- Conditions the study is for
- Otitis Media With Effusion
- What is being tested?
- bilateral myringotomy, bilateral myringotomy and tubes and adenoidectomy
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Feb 1997to Jan 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 47 months
- All sexes
- No healthy volunteers
- Child
- Males and females between 24 and 47 months of age, in good general health.
- Asymptomatic otitis media with effusion bilaterally for a minimum of 3 consecutive months.
- At least one 10-day course of a broad-spectrum antimicrobial agent in the last month.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ear, Nose, and Throat Research Center, Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213-2583
About this study
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.
Read the detailed description
The specific aim of this study is to compare, by means of a randomized clinical trial, the efficacy of three surgical treatment combinations: adenoidectomy with myringotomy (A-M), adenoidectomy with myringotomy and tympanostomy tube insertion (A-M\&T), and M\&T alone, in reducing subsequent middle ear disease in children aged 24-47 months with otitis media with effusion (OME) of at least 3 months' duration unresponsive to standardized, recent antimicrobial treatment. The children are randomly assigned to one of three treatment arms: 1. M\&T; 2. A-M; and 3. A-M\&T. Subjects are be stratified according to: 1. age; 2. nasal obstruction; and 3. previous tubes. All subjects are scheduled for surgery according to assignment within 4 weeks after entry. The first post-operative visit takes place 2 weeks after surgery, and a complete examination of the ears, nose, and throat (ENT exam) including pneumatic otoscopy, tympanometry and audiometry is performed. Subjects are followed with monthly evaluations (ENT-exam, pneumatic otoscopy, tympanometry) for three years. Audiometry is performed every 6 months. All subjects are evaluated at any time while still enrolled in the study if signs and symptoms of URI, acute otitis media (AOM, including otorrhea), or OME occur and are treated appropriately. Subjects who develop OME for 4 months bilaterally or 6 months unilaterally have M\&T and continue to be followed in the study. The primary outcome measure will be percentage of time with middle ear effusion (MEE). Episodes of AOM, otorrhea, and OME, time to first recurrence, and number of surgical procedures will be compared between the three treatment groups. Treatment failures, complications and sequelae of treatments will also be recorded and compared among the three treatment groups.
- Conditions
- Otitis Media With Effusion
- Being tested
- bilateral myringotomy, bilateral myringotomy and tubes, adenoidectomy
- Keywords
- otitis media with effusion, children, tympanostomy tubes, adenoidectomy
- Medical subject headings
- Otitis Media with Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral myringotomyProcedure or surgery
bilateral myringotomy and tubesProcedure or surgery
adenoidectomyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2001 (estimated)
- Study startFeb 1997
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis Media With EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
Sponsor and investigators
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Margaretha L Casselbrant, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00016497
- Sponsor's protocol ID
- NIDCD1RO1DC035-04
- Status last verified
- Apr 2006
- First submitted
- 10 May 2001
- Last updated
- 24 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adenoidectomy for Otitis Media in 2-3 Year Old Children
- ClinicalTrials.gov ID
- NCT00016497
- Acronym / sponsor ID
- NIDCD1RO1DC035-04
- Conditions
- Otitis Media With Effusion
- Keywords
- otitis media with effusion, children, tympanostomy tubes, adenoidectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)US National Institutes of Health
- Study start
- Feb 1997
- Study completion
- Jan 2007
- First posted
- 14 May 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The specific aim of this study is to compare, by means of a randomized clinical trial, the efficacy of three surgical treatment combinations: adenoidectomy with myringotomy (A-M), adenoidectomy with myringotomy and tympanostomy tube insertion (A-M\&T), and M\&T alone, in reducing subsequent middle ear disease in children aged 24-47 months with otitis media with effusion (OME) of at least 3 months' duration unresponsive to standardized, recent antimicrobial treatment. The children are randomly assigned to one of three treatment arms: 1. M\&T; 2. A-M; and 3. A-M\&T. Subjects are be stratified according to: 1. age; 2. nasal obstruction; and 3. previous tubes. All subjects are scheduled for surgery according to assignment within 4 weeks after entry. The first post-operative visit takes place 2 weeks after surgery, and a complete examination of the ears, nose, and throat (ENT exam) including pneumatic otoscopy, tympanometry and audiometry is performed. Subjects are followed with monthly evaluations (ENT-exam, pneumatic otoscopy, tympanometry) for three years. Audiometry is performed every 6 months. All subjects are evaluated at any time while still enrolled in the study if signs and symptoms of URI, acute otitis media (AOM, including otorrhea), or OME occur and are treated appropriately. Subjects who develop OME for 4 months bilaterally or 6 months unilaterally have M\&T and continue to be followed in the study. The primary outcome measure will be percentage of time with middle ear effusion (MEE). Episodes of AOM, otorrhea, and OME, time to first recurrence, and number of surgical procedures will be compared between the three treatment groups. Treatment failures, complications and sequelae of treatments will also be recorded and compared among the three treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 24 to 47 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bilateral myringotomy | Procedure or surgery | – |
| bilateral myringotomy and tubes | Procedure or surgery | – |
| adenoidectomy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaretha L Casselbrant principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bilateral myringotomy, bilateral myringotomy and tubes and adenoidectomy in people with Otitis Media With Effusion, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2006.