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Open Access 01-12-2022 | Ear Disease | Study protocol

INFLATE: a protocol for a randomised controlled trial comparing nasal balloon autoinflation to no nasal balloon autoinflation for otitis media with effusion in Aboriginal and Torres Strait Islander children

Authors: Robyn Walsh, Jennifer Reath, Hasantha Gunasekera, Amanda Leach, Kelvin Kong, Deborah Askew, Federico Girosi, Wendy Hu, Timothy Usherwood, Sanja Lujic, Geoffrey Spurling, Peter Morris, Chelsea Watego, Samantha Harkus, Cheryl Woodall, Claudette Tyson, Letitia Campbell, Sylvia Hussey, Penelope Abbott

Published in: Trials | Issue 1/2022

Abstract

Background

Otitis media with effusion (OME) is common and occurs at disproportionately higher rates among Indigenous children. Left untreated, OME can negatively affect language, development, learning, and health and wellbeing throughout the life-course. Currently, OME care includes observation for 3 months followed by consideration of surgical ventilation tube insertion. The use of a non-invasive, low-cost nasal balloon autoinflation device has been found beneficial in other populations but has not been investigated among Aboriginal and Torres Strait Islander children.

Methods/design

This multi-centre, open-label, randomised controlled trial will determine the effectiveness of nasal balloon autoinflation compared to no nasal balloon autoinflation, for the treatment of OME among Aboriginal and Torres Strait Islander children in Australia. Children aged 3–16 years with unilateral or bilateral OME are being recruited from Aboriginal Health Services and the community. The primary outcome is the proportion of children showing tympanometric improvement of OME at 1 month. Improvement is defined as a change from bilateral type B tympanograms to at least one type A or C1 tympanogram, or from unilateral type B tympanogram to type A or C1 tympanogram in the index ear, without deterioration (type A or C1 to type C2, C3, or B tympanogram) in the contralateral ear. A sample size of 340 children (170 in each group) at 1 month will detect an absolute difference of 15% between groups with 80% power at 5% significance. Anticipating a 15% loss to follow-up, 400 children will be randomised. The primary analysis will be by intention to treat. Secondary outcomes include tympanometric changes at 3 and 6 months, hearing at 3 months, ear health-related quality of life (OMQ-14), and cost-effectiveness. A process evaluation including perspectives of parents or carers, health care providers, and researchers on trial implementation will also be undertaken.

Discussion

INFLATE will answer the important clinical question of whether nasal balloon autoinflation is an effective and acceptable treatment for Aboriginal and Torres Strait Islander children with OME. INFLATE will help fill the evidence gap for safe, low-cost, accessible OME therapies.

Trial registration

Australia New Zealand Clinical Trials Registry ACTRN12617001652369. Registered on 22 December 2017. The Australia New Zealand Clinical Trials Registry is a primary registry of the WHO ICTRP network and includes all items from the WHO Trial Registration data set. Retrospective registration.

Available only for authorised users

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Title: INFLATE: a protocol for a randomised controlled trial comparing nasal balloon autoinflation to no nasal balloon autoinflation for otitis media with effusion in Aboriginal and Torres Strait Islander children
Authors: Robyn Walsh
Jennifer Reath
Hasantha Gunasekera
Amanda Leach
Kelvin Kong
Deborah Askew
Federico Girosi
Wendy Hu
Timothy Usherwood
Sanja Lujic
Geoffrey Spurling
Peter Morris
Chelsea Watego
Samantha Harkus
Cheryl Woodall
Claudette Tyson
Letitia Campbell
Sylvia Hussey
Penelope Abbott
Publication date: 01-12-2022
Publisher: BioMed Central
Keyword: Ear Disease
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06145-8

Keynote webinar | Spotlight on medication adherence

Springer Medicine

INFLATE: a protocol for a randomised controlled trial comparing nasal balloon autoinflation to no nasal balloon autoinflation for otitis media with effusion in Aboriginal and Torres Strait Islander children

Abstract

Background

Methods/design

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods/design

Discussion

Trial registration

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