The effects of ventilation tubes versus no ventilation tubes for recurrent acute otitis media or chronic otitis media with effusion in 9 to 36 month old Greenlandic children, the SIUTIT trial: study protocol for a randomized controlled trial

Autor: Christian Gluud, Ramon Gordon Jensen, Janus Christian Jakobsen, Malene Nøhr Demant, Preben Homøe
Rok vydání: 2016
Předmět:
Male
Pediatrics
Time Factors
Greenland
Medicine (miscellaneous)
Health Services Accessibility
law.invention
Study Protocol
0302 clinical medicine
Superiority Trial
Randomized controlled trial
Quality of life
Clinical Protocols
law
Recurrence
Pharmacology (medical)
030223 otorhinolaryngology
education.field_of_study
Tympanic Membrane Perforation
Medical record
Equipment Design
Anti-Bacterial Agents
Treatment Outcome
Effusion
Research Design
Chest Tubes
Child
Preschool
Acute Disease
Female
Randomized clinical trials
medicine.symptom
medicine.medical_specialty
Randomization
Population
Grommets
03 medical and health sciences
Double-Blind Method
030225 pediatrics
medicine
Journal Article
Humans
education
Otitis media
business.industry
Otitis Media with Effusion
Ventilation tubes
Infant
Middle Ear Ventilation
Respiration
Artificial
Otitis
Quality of Life
Rural Health Services
business
Zdroj: Trials
Demant, M N, Jensen, R G, Jakobsen, J C, Gluud, C & Homøe, P 2017, ' The effects of ventilation tubes versus no ventilation tubes for recurrent acute otitis media or chronic otitis media with effusion in 9 to 36 month old Greenlandic children, the SIUTIT trial : study protocol for a randomized controlled trial ', Trials, vol. 18, 30 . https://doi.org/10.1186/s13063-016-1770-x
ISSN: 1745-6215
DOI: 10.1186/s13063-016-1770-x
Popis: Background The prevalence of otitis media in Greenlandic children is one of the highest in the world. International studies have shown that otitis-prone children may benefit from tubulation of the tympanic membrane. However, it is unknown whether these results can be applied to Greenlandic children and trials on the effects of ventilation tubes in high-risk populations have, to our knowledge, never been conducted. Methods The trial is an investigator-initiated, multicentre, randomized, blinded superiority trial of bilateral ventilation tube insertion versus treatment as usual (no tube) in Greenlandic children aged 9–36 months with chronic otitis media with effusion or recurrent acute otitis media. With randomization stratified by otitis media subtype and trial site, a type 1 error of 5% and a power of 80%, a total of 230 participants are needed to detect a decrease of two visits to a health clinic during 2 years, which is considered the minimal clinical relevant difference. The primary outcome measure will be assessed blindly by investigating medical records. Secondary outcome measures are number of episodes of acute otitis media, quality of life, number of episodes of antibiotics administration and proportion of children with tympanic membrane perforations. Discussion This trial will provide evidence-based knowledge of the effects of ventilation tubes in children with middle ear infections from the high-risk Greenlandic population. Furthermore, this trial will improve the understanding of conducting randomized clinical trials in remote areas, where management of logistical aspects is particularly challenging. Trial registration ClinicalTrials.gov, NCT02490332. Registered on 14 February 2016. Electronic supplementary material The online version of this article (doi:10.1186/s13063-016-1770-x) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
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