INFLATE (ACTRN12617001652369).

Study name	'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'
Methods	Multicentre, open‐label, parallel‐group randomised controlled trial
Participants	Aboriginal and Torres Strait Islander children aged 3 to 16 years old with unilateral or bilateral OME Estimated enrolment 400 participants
Interventions	Nasal balloon autoinflation using the Otovent device (2 times per day for 1 to 3 months) compared to no treatment
Outcomes	Tympanometric improvement in OME at 1 month, 3 months and 6 months (change from type B to type A or C1 tympanogram in affected ears) Hearing at 3 months Ear health‐related quality of life using the OMQ‐14 Adverse events Adherence to treatment Cost‐effectiveness
Starting date	December 2017
Contact information	P.Abbott@westernsydney.edu.au
Notes	—