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Effect of Ventilation Tubes in Otitis-prone Children

Primary Purpose

Recurrent Acute Otitis Media

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
ventilation tubes
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Recurrent Acute Otitis Media focused on measuring ventilation tubes, prevention, quality of life, antibiotic treatment, otitis media with effusion, audiometry, watchful waiting, tympanic membrane perforation

Eligibility Criteria

1 Year - 2 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: At inclusion, children should be under 1 year of age and fulfil the internationally accepted definition of recurrent AOM, ie have had 3 episodes of AOM during the last 6 months, or 4 during the last 12 months.

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Exclusion Criteria: chromosomal aberrations, cleft palate or severe immune deficiency

-

Sites / Locations

  • Department of Otorhinolaryngology, Head and Neck SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Ventilation tubes

Active monitoring

Arm Description

Ventilation tube surgery

Active monitoring of patients, with the possibility to cross over to other arm if deemed necessary.

Outcomes

Primary Outcome Measures

Antibiotic prescriptions
Number of oral antibiotic prescriptions
Otitis media episodes
Number of otitis media episodes

Secondary Outcome Measures

Microbiology
Nasopharyngeal and middle ear growth during acute otitis media episodes
Tympanic membrane perforations
Presence of chronic tympanic membrane perforations
Audiometry
Audiometry, including high frequency audiometry

Full Information

First Posted
April 21, 2022
Last Updated
March 16, 2023
Sponsor
Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT05348291
Brief Title
Effect of Ventilation Tubes in Otitis-prone Children
Official Title
Ventilation Tubes for Recurrent Acute Otitis Media - Effects on Antibiotic Consumption and Otitis Media Episodes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 21, 2022 (Actual)
Primary Completion Date
May 2028 (Anticipated)
Study Completion Date
May 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the effects of ventilation tubes in children with recurrent ear infections. By drawing lots, young children with recurrent ear infections will be assigned to one of two groups (ventilation tubes or close follow-up), and the number of ear infections and antibiotic prescriptions in each group will be monitored. The study participants will be followed until they are 7 years old.
Detailed Description
Children who fulfil the criteria of recurrent acute otitis media (AOM) before they are one year of age will be randomised to ventilation tube surgery or active monitoring (50% vs 50%). Due to the nature of the intervention, blinding will not be possible. Children randomised to are randomised to active monitoring and continue to have frequent recurrences will be given the opportunity to cross between groups. Children will be followed by the study doctors every third month until the age of two years, and after this yearly. In addition to planned visits, the families will be advised to contact the study doctors whenever they suspect that their child has a new episode of AOM. Otomicroscopy and nasopharyngeal cultures will be performed at every visit; cultures from the external ear canal will be taken when applicable. It will also be noted whether there is any perforation of the tympanic membrane, whether ventilation tubes are still in place, whether there is an ongoing episode of AOM or of otitis media with effusion (OME). At each planned visit, a parental quality of life questionnaire for children with ear disease will be completed. It will be noted how many AOM episodes the child has had since the last planned visit, how many times the patient has been prescribed oral antibiotics (also for reasons other than AOM), and if the family has seen a doctor elsewhere. At each emergency visit, it will be noted if the child has AOM or not, whether the child has fever, any signs of complications to AOM, a spontaneous perforation and whether the child´s general well-being is affected. At the ages of 4 and 7 years and, if a hearing impairment is suspected on any other occasion, hearing tests will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Acute Otitis Media
Keywords
ventilation tubes, prevention, quality of life, antibiotic treatment, otitis media with effusion, audiometry, watchful waiting, tympanic membrane perforation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Unblinded, randomised controlled trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ventilation tubes
Arm Type
Active Comparator
Arm Description
Ventilation tube surgery
Arm Title
Active monitoring
Arm Type
No Intervention
Arm Description
Active monitoring of patients, with the possibility to cross over to other arm if deemed necessary.
Intervention Type
Device
Intervention Name(s)
ventilation tubes
Other Intervention Name(s)
grommets
Intervention Description
Transtympanic pressure equalising devices.
Primary Outcome Measure Information:
Title
Antibiotic prescriptions
Description
Number of oral antibiotic prescriptions
Time Frame
First two years in study
Title
Otitis media episodes
Description
Number of otitis media episodes
Time Frame
First two years in study
Secondary Outcome Measure Information:
Title
Microbiology
Description
Nasopharyngeal and middle ear growth during acute otitis media episodes
Time Frame
First two years in study
Title
Tympanic membrane perforations
Description
Presence of chronic tympanic membrane perforations
Time Frame
Until age 7
Title
Audiometry
Description
Audiometry, including high frequency audiometry
Time Frame
At age 4 and 7 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At inclusion, children should be under 1 year of age and fulfil the internationally accepted definition of recurrent AOM, ie have had 3 episodes of AOM during the last 6 months, or 4 during the last 12 months. - Exclusion Criteria: chromosomal aberrations, cleft palate or severe immune deficiency -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Gisselsson-Solen, MD, PhD
Phone
+4646172815
Email
marie.gisselsson-solen@med.lu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Ann Hermansson, Professor
Phone
+4646171360
Email
ann.hermansson@med.lu.se
Facility Information:
Facility Name
Department of Otorhinolaryngology, Head and Neck Surgery
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomas Andersson-Kronmark, MD
Email
tomas.kronmark@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Effect of Ventilation Tubes in Otitis-prone Children

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