Otitis Media With Effusion in ChildrenNCT05545345
Adjuvant Adenoidectomy for the Treatment of Chronic OME in Children
A study testing tympanostomy tube placement and adenoidectomy in people with Otitis Media With Effusion in Children, run by Eye & ENT Hospital of Fudan University.
Trial summary
This study aims to verify the efficacy of adjuvant adenoidectomy for children with chronic OME who become candidates for tympanostomy tube placement, and explore potential factors associated with the efficacy of adjuvant adenoidectomy. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Otitis Media With Effusion in Children
- What is being tested?
- tympanostomy tube placement and adenoidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Sep 2025
- Phase
- Interventional
- 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. Children 4-12 years of age.
- 2. Diagnosed with chronic OME. Diagnostic criteria: I. Middle ear effusion detected by otoscopy; II. Type B or C tympanograms; III. Symptoms/signs of OME persisted for >3 months;
- 3. Documented hearing loss ≥20dB (average threshold of 500Hz, 1000Hz and 2kHz in pure tone audiometry).
- 4. Adenoid hypertrophy (A/N ratio> 0.5 in lateral radiography of the nasopharynx).
- 5. Informed consent given by the patients and their guardians.
Who cannot join
- Cleft palate or other systemic disorders.
- Patients are diagnosed with other nose, sinuses or ear diseases that are eligible for surgical treatment.
- Patients are diagnosed with OSAHS, tonsil hypertrophy ≥II° or scheduled for tonsillectomy.
- History of tympanostomy tube placement.
- Infection of the upper respiratory tract or acute rhinosinusitis over the past 7 days.
- Sensorineural hearing loss.
- Other situations that the investigators find unsuitable for the trial.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Adjuvant Adenoidectomy Plus Tympanostomy Tube Placement for the Treatment of Chronic OME in Children
This study aims to verify the efficacy of adjuvant adenoidectomy for children with chronic OME who become candidates for tympanostomy tube placement, and explore potential factors associated with the efficacy of adjuvant adenoidectomy.
Read the detailed description
Otitis media with effusion is a common condition in children, and tympanostomy tube placement is the first-line treatment for those who requires surgical interventions. Adenoidectomy proves to be helpful to children over 4 years old, but the risks of adjuvant surgery is believed to somehow offset its benefits. This study is meant to verify if concurrent adenoidectomy provides extra benefits in resolving MEE, reducing AOM, and improving hearing and patients' quality of life to children who become candidates for TT.
- Conditions
- Otitis Media With Effusion in Children
- Being tested
- tympanostomy tube placement, adenoidectomy
- Keywords
- Otitis media with effusion, tympanostomy tube placement, adjuvant adenoidectomy, hearing outcome
- 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.
tympanostomy tube placementProcedure or surgery
An incision will be made in the the tympanic membrane, through which a ventilation tube will be inserted.
adenoidectomyProcedure or surgery
The adenoid is resected transorally under a 70° endoscope with microdebrider or coblator until torus tubarius and choanae are completely revealed.
| Study group | Role | What they receive |
|---|---|---|
| TT | Active comparator | Participants only receive tympanostomy tube placement. Receives: Procedure: tympanostomy tube placement |
| Ad+TT | Experimental | Participants will receive tympanostomy tube placement and concurrent adenoidectomy. Receives: Procedure: tympanostomy tube placement; Procedure: adenoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
Rate of OME recurrence
Measured: 1 year after tube removal
Rate of repeated tube placement
proportion of patients who need repeated tube insertion
Measured: 1 year after tube removal
Secondary outcomes (6)
AOM attacks
The number of acute otitis media attacks
Measured: 1 year after tube removal
Otorrhea
Rate of Otorrhea
Measured: 2 years after tube insertion
Pure tone audiometry
Change of pure tone audiometry thresholds compared with baseline
Measured: 2 years after tube insertion
Otitis Media-6 and Pediatric Sleep Questionnaire
Change of questionnaire score. Otitis Media-6 score ranges from 6 to 42, and higher scores mean worse outcomes. Pediatric Sleep Questionnaire score ranges from 0 to 22, and higher scores mean worse outcomes.
Measured: 2 years after tube insertion
Complications
Complications related to interventions of this study
Measured: 2 years after tube insertion
Costs of OME-related visits and treatment
Medical expenses associated with OME
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study startSep 2022 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis Media With Effusion in ChildrenStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Children's Hospital of Fudan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545345
- Sponsor's protocol ID
- 2022-AdOME
- Status last verified
- Sep 2022
- First submitted
- 4 Aug 2022
- Last updated
- 19 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Adenoidectomy Plus Tympanostomy Tube Placement for the Treatment of Chronic OME in Children
- ClinicalTrials.gov ID
- NCT05545345
- Acronym / sponsor ID
- 2022-AdOME
- Conditions
- Otitis Media With Effusion in Children
- Keywords
- Otitis media with effusion, tympanostomy tube placement, adjuvant adenoidectomy, hearing outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Children's Hospital of Fudan University
- Study start
- Sep 2022 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 19 Sep 2022 (actual)
- 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.
This study aims to verify the efficacy of adjuvant adenoidectomy for children with chronic OME who become candidates for tympanostomy tube placement, and explore potential factors associated with the efficacy of adjuvant adenoidectomy.
Detailed description
Otitis media with effusion is a common condition in children, and tympanostomy tube placement is the first-line treatment for those who requires surgical interventions. Adenoidectomy proves to be helpful to children over 4 years old, but the risks of adjuvant surgery is believed to somehow offset its benefits. This study is meant to verify if concurrent adenoidectomy provides extra benefits in resolving MEE, reducing AOM, and improving hearing and patients' quality of life to children who become candidates for TT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TT | Active comparator | Procedure: tympanostomy tube placementParticipants only receive tympanostomy tube placement. |
| Ad+TT | Experimental | Procedure: tympanostomy tube placement, Procedure: adenoidectomyParticipants will receive tympanostomy tube placement and concurrent adenoidectomy. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 1. Children 4-12 years of age.
- 2. Diagnosed with chronic OME. Diagnostic criteria: I. Middle ear effusion detected by otoscopy; II. Type B or C tympanograms; III. Symptoms/signs of OME persisted for >3 months;
- 3. Documented hearing loss ≥20dB (average threshold of 500Hz, 1000Hz and 2kHz in pure tone audiometry).
- 4. Adenoid hypertrophy (A/N ratio> 0.5 in lateral radiography of the nasopharynx).
- 5. Informed consent given by the patients and their guardians.
Key exclusion criteria (7 listed)
- Cleft palate or other systemic disorders.
- Patients are diagnosed with other nose, sinuses or ear diseases that are eligible for surgical treatment.
- Patients are diagnosed with OSAHS, tonsil hypertrophy ≥II° or scheduled for tonsillectomy.
- History of tympanostomy tube placement.
- Infection of the upper respiratory tract or acute rhinosinusitis over the past 7 days.
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 |
|---|---|---|
| tympanostomy tube placementAn incision will be made in the the tympanic membrane, through which a ventilation tube will be inserted. | Procedure or surgery | Ad+TT, TT |
| adenoidectomyThe adenoid is resected transorally under a 70° endoscope with microdebrider or coblator until torus tubarius and choanae are completely revealed. | Procedure or surgery | Ad+TT |
Primary outcome
Recurrence rate
Time frame: 1 year after tube removal
Rate of OME recurrence
Rate of repeated tube placement
Time frame: 1 year after tube removal
proportion of patients who need repeated tube insertion
6 secondary outcomes
AOM attacks
Time frame: 1 year after tube removal
Otorrhea
Time frame: 2 years after tube insertion
Pure tone audiometry
Time frame: 2 years after tube insertion
Otitis Media-6 and Pediatric Sleep Questionnaire
Time frame: 2 years after tube insertion
Complications
Time frame: 2 years after tube insertion
Costs of OME-related visits and treatment
Time frame: Through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing tympanostomy tube placement and adenoidectomy in people with Otitis Media With Effusion in Children, run by Eye & ENT Hospital of Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huiqian Yu, PhD (86-13636423139, yhq925@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: 1 year after tube removal). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 19 Sep 2022.