Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2017 Jan 19;18(1):30.
doi: 10.1186/s13063-016-1770-x.

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

Malene Nøhr Demant  1 , Ramon Gordon Jensen  2 , Janus Christian Jakobsen  3   4 , Christian Gluud  3 , Preben Homøe  5   6
Affiliations
Randomized Controlled Trial

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

Malene Nøhr Demant et al. Trials. .

Abstract

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.

Keywords: Grommets; Otitis media; Randomized clinical trials; Ventilation tubes.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Consolidated Standards of Reporting Trials (CONSORT) trial flow chart
Fig. 2
Fig. 2
Inclusion procedure flowchart. AOM, acute otitis media; ENT, ear, nose and throat; OME, otitis media with effusion
See this image and copyright information in PMC

References

    1. Rosenfeld RM, Schwartz SR, Pynnonen MA, Tunkel DE, Hussey HM, Fichera JS, Grimes AM, Hackell JM, Harrison MF, Haskell H, Haynes DS, Kim TW, Lafreniere DC, LeBlanc K, Mackey WL, et al. Clinical practice guideline: tympanostomy tubes in children. Otolaryngol Head Neck Surg. 2013;149(1 Suppl):S1–35. doi: 10.1177/0194599813487302. - DOI - PubMed
    1. Sidell D, Shapiro NL, Bhattacharyya N. Demographic influences on antibiotic prescribing for pediatric acute otitis media. Otolaryngol Head Neck Surg. 2012;146(4):653–8. doi: 10.1177/0194599811431228. - DOI - PubMed
    1. Rosenfeld RM, Shin JJ, Schwartz SR, Coggins R, Gagnon L, Hackell JM, Hoelting D, Hunter LL, Kummer AW, Payne SC, Poe DS, Veling M, Vila PM, Walsh SA, Corrigan MD. Clinical practice guideline: otitis media with effusion executive summary (update) Otolaryngol Head Neck Surg. 2016;154(2):201–14. doi: 10.1177/0194599815624407. - DOI - PubMed
    1. Ahmed S, Shapiro NL, Bhattacharyya N. Incremental health care utilization and costs for acute otitis media in children. Laryngoscope. 2014;124(1):301–5. doi: 10.1002/lary.24190. - DOI - PubMed
    1. Homøe P, Jensen RG. Mellemørebetændelse i Grønland (Middle ear infections in Greenland) Månedsskrift for Almen Praksis (Journal of The Danish College of General Practitioners) 2013;91:228–37.

Publication types

MeSH terms

Substances

Associated data