NCT05348291

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
85mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress34%
Oct 2022May 2033

First Submitted

Initial submission to the registry

April 21, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 27, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

October 21, 2022

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2033

Last Updated

March 20, 2023

Status Verified

March 1, 2023

Enrollment Period

5.5 years

First QC Date

April 21, 2022

Last Update Submit

March 16, 2023

Conditions

Recurrent Acute Otitis Media

Keywords

ventilation tubespreventionquality of lifeantibiotic treatmentotitis media with effusionaudiometrywatchful waitingtympanic membrane perforation

Outcome Measures

Primary Outcomes (2)

  • Antibiotic prescriptions

    Number of oral antibiotic prescriptions

    First two years in study

  • Otitis media episodes

    Number of otitis media episodes

    First two years in study

Secondary Outcomes (3)

  • Microbiology

    First two years in study

  • Tympanic membrane perforations

    Until age 7

  • Audiometry

    At age 4 and 7 years

Study Arms (2)

Ventilation tubes

ACTIVE COMPARATOR

Ventilation tube surgery

Device: ventilation tubes

Active monitoring

NO INTERVENTION

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

Interventions

ventilation tubesDEVICE

Transtympanic pressure equalising devices.

Also known as: grommets
Ventilation tubes

Eligibility Criteria

Age1 Year - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Otorhinolaryngology, Head and Neck Surgery

Lund, 22185, Sweden

RECRUITING

MeSH Terms

Conditions

Otitis MediaOtitis Media with EffusionTympanic Membrane Perforation

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic DiseasesWounds and Injuries

Central Study Contacts

Marie Gisselsson-Solen, MD, PhD

CONTACT

+4646172815marie.gisselsson-solen@med.lu.se

Ann Hermansson, Professor

CONTACT

+4646171360ann.hermansson@med.lu.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Unblinded, randomised controlled trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2022

First Posted

April 27, 2022

Study Start

October 21, 2022

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2033

Last Updated

March 20, 2023

Record last verified: 2023-03

Locations

SE(1)