Otitis Media With Effusion in ChildrenNCT06909084
Hearing Improvement After Making a Hole Surgically in Eardrum With or Without Ventilation Tube in Children With Glue Ears
A study testing Myringotomy with ventilation tube and Myringotomy alone in people with Otitis Media With Effusion in Children and Hearing Loss, run by Allama Iqbal Teaching Hospital at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to compare the effectiveness of myringotomy with ventilation tube insertion to myringotomy alone in improving hearing in children with glue ear. Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Otitis Media With Effusion in Children, Hearing Loss
- What is being tested?
- Myringotomy with ventilation tube and Myringotomy alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2024to 31 Dec 2024
- 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 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- cases of otitis media with effusion
- more than 20 decibel (dB) conductive hearing loss on pure tone audiometry
- non-responder to medical treatment after three months of medical treatment
Who cannot join
- Children having recurrent otitis media
- Discharging ears
- History of bleeding disorder
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Allama Iqbal Teaching Hospital Dera Ghazi Khan
Dera Ghazi Khan, Punjab Province, 32200
About this study
Official title: Comparison of Outcome of Myringotomy With or Without Ventilation Tube in Children With Glue Ears
The goal of this clinical trial is to compare the effectiveness of myringotomy with ventilation tube insertion to myringotomy alone in improving hearing in children with glue ear.
The main question it aims to answer is:
Read more
Does adding a ventilation tube to myringotomy lead to greater improvement in hearing compared to myringotomy alone? Researchers will compare these two surgical techniques to determine which offers better outcomes for children with otitis media with effusion.
The Participants will:
- Have their hearing evaluated before surgery
- Undergo either myringotomy with ventilation tube insertion or myringotomy alone
- Have their hearing evaluated at follow-up visits at 2 weeks, 1 month, and 3 months post-operatively
- Being tested
- Myringotomy with ventilation tube, Myringotomy alone
- Keywords
- Otitis Media with Effusion, Hearing Loss, Children, Middle ear Ventilation
- Medical subject headings
- Hearing Loss, Otitis Media with Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myringotomy with ventilation tubeProcedure or surgery
Under microscope tympanic membrane was visualized after cleaning the external auditory canal and myringotomy incision was given with the help of myringotome in anteroinferior quadrant of tympanic membrane. Secretions from middle ear were drained by suction. A tympanostomy tube (Shepard tube) of appropriate size was placed in the incision and canal was packed with bismuth iodoform paraffin paste which was removed after 24 hours.
Myringotomy aloneProcedure or surgery
Under microscope tympanic membrane was visualized after cleaning the external auditory canal and myringotomy incision was given with the help of myringotome in anteroinferior quadrant of tympanic membrane. Secretions from middle ear were drained by suction. NO FURTHER PROCEDURE WAS DONE and canal was packed with bismuth iodoform paraffin paste which was removed after 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Myringotomy with Ventilation tube | Experimental | A tympanostomy tube (Shepard tube) of appropriate size will be placed in the incision and canal will be packed with bismuth iodoform paraffin paste (BIPP) Receives: Procedure: Myringotomy with ventilation tube |
| Myringotomy alone | Active comparator | Incision in the eardrum (myringotomy) will be made. Middle ear canal will be cleaned after draining the fluid and the canal will be packed with bismuth iodoform paraffin paste (BIPP) Receives: Procedure: Myringotomy alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in hearing
The degree of hearing loss (dB) on pure tone audiometry was done before and after surgical procedure. Improvement in hearing level was labelled if there was decrease in hearing loss of 25% from baseline.
Measured: Before and Three months post operatively
Secondary outcomes (2)
Hearing Loss (dB)
All patients underwent pure tone audiometry for assessment of hearing loss (dB)
Measured: Before and Three months post operatively
Degree of Hearing Loss
The degree of hearing loss (dB) on pure tone audiometry was done before and after surgical procedure. Degree of hearing loss was labelled as mild (20-40 dB), moderate (40-60 dB) and severe (60-80 dB).
Measured: Before and Three months post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start1 Jan 2024
- Primary completion30 Sep 2024
- Study completion31 Dec 2024
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.
- 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allama Iqbal Teaching Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Mudasir Abbas, Allama Iqbal Teaching Hospital
- Investigators
- Dr. Sharbaz Hussain Khosa, FCPS, Study chair, Allama Iqbal Teaching Hospital Dera Ghazi Khan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909084
- Sponsor's protocol ID
- U1111-1317-1361
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) might not be shared because it contains sensitive personal health information. Sharing such data could compromise participant confidentiality and privacy, and may conflict with ethical guidelines, informed consent, and regulatory requirements.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcome of Myringotomy With or Without Ventilation Tube in Children With Glue Ears
- ClinicalTrials.gov ID
- NCT06909084
- Acronym / sponsor ID
- U1111-1317-1361
- Keywords
- Otitis Media with Effusion, Hearing Loss, Children, Middle ear Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Allama Iqbal Teaching HospitalOther government
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 3 Apr 2025 (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.
The goal of this clinical trial is to compare the effectiveness of myringotomy with ventilation tube insertion to myringotomy alone in improving hearing in children with glue ear.
The main question it aims to answer is:
Does adding a ventilation tube to myringotomy lead to greater improvement in hearing compared to myringotomy alone? Researchers will compare these two surgical techniques to determine which offers better outcomes for children with otitis media with effusion.
The Participants will:
- Have their hearing evaluated before surgery
- Undergo either myringotomy with ventilation tube insertion or myringotomy alone
- Have their hearing evaluated at follow-up visits at 2 weeks, 1 month, and 3 months post-operatively
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myringotomy with Ventilation tube | Experimental | Procedure: Myringotomy with ventilation tubeA tympanostomy tube (Shepard tube) of appropriate size will be placed in the incision and canal will be packed with bismuth iodoform paraffin paste (BIPP) |
| Myringotomy alone | Active comparator | Procedure: Myringotomy aloneIncision in the eardrum (myringotomy) will be made. Middle ear canal will be cleaned after draining the fluid and the canal will be packed with bismuth iodoform paraffin paste (BIPP) |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- cases of otitis media with effusion
- more than 20 decibel (dB) conductive hearing loss on pure tone audiometry
- non-responder to medical treatment after three months of medical treatment
Key exclusion criteria (3 listed)
- Children having recurrent otitis media
- Discharging ears
- History of bleeding disorder
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 |
|---|---|---|
| Myringotomy with ventilation tubeUnder microscope tympanic membrane was visualized after cleaning the external auditory canal and myringotomy incision was given with the help of myringotome in anteroinferior quadrant of tympanic membrane. Secretions from middle ear were drained by suction. A tympanostomy tube (Shepard tube) of appropriate size was placed in the incision and canal was packed with bismuth iodoform paraffin paste which was removed after 24 hours. | Procedure or surgery | Myringotomy with Ventilation tube |
| Myringotomy aloneUnder microscope tympanic membrane was visualized after cleaning the external auditory canal and myringotomy incision was given with the help of myringotome in anteroinferior quadrant of tympanic membrane. Secretions from middle ear were drained by suction. NO FURTHER PROCEDURE WAS DONE and canal was packed with bismuth iodoform paraffin paste which was removed after 24 hours. | Procedure or surgery | Myringotomy alone |
Primary outcome
Improvement in hearing
Time frame: Before and Three months post operatively
The degree of hearing loss (dB) on pure tone audiometry was done before and after surgical procedure. Improvement in hearing level was labelled if there was decrease in hearing loss of 25% from baseline.
2 secondary outcomes
Hearing Loss (dB)
Time frame: Before and Three months post operatively
Degree of Hearing Loss
Time frame: Before and Three months post operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) might not be shared because it contains sensitive personal health information. Sharing such data could compromise participant confidentiality and privacy, and may conflict with ethical guidelines, informed consent, and regulatory requirements.
Related trials for Otitis Media With Effusion in Children
Recruiting
Towards Implementation of Universal Newborn Hearing Screening in Kenya
Hearing Loss, Bilateral or Unilateral, Otitis Media With Effusion in Children
Recruiting
CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes
Otitis Media, Otitis Media Chronic
Not yet recruiting
Osteopathic Manipulative Treatment for Children With Chronic or Recurrent Otitis Media
Otitis Media, Otitis Media Effusion
Active, not recruitingObservational study
Otitis Treatment With OtoSight™ - Modification of Antibiotic Treatment Intervention in Children
Otitis Media Acute
Active, not recruiting
Posterior vs. Anterior Tympanostomy Tube Placement
Otitis Media in Children, Chronic Otitis Media With Effusion
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.
Dr. Sharbaz Hussain Khosa, FCPS study chair
Allama Iqbal Teaching Hospital Dera Ghazi Khan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myringotomy with ventilation tube and Myringotomy alone in people with Otitis Media With Effusion in Children and Hearing Loss, run by Allama Iqbal Teaching Hospital at 1 site in Pakistan.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 3 Apr 2025. 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 Pakistan. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Improvement in hearing (time frame: Before and Three months post operatively). 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 3 Apr 2025.