Author Identifier (ORCID)

Natalie Strobel: https://orcid.org/0000-0002-2962-5704

Daniel McAullay: https://orcid.org/0000-0002-0651-899X

Abstract

Introduction: Otitis media with effusion (OME) affects hearing, speech development, and quality of life (QoL) in children. The ‘Blow, Breathe, Cough’ (BBC) intervention promotes nasal, respiratory, and middle ear clearance through nose blowing, deep breathing, coughing, and hand hygiene. It shows promise in resolving OME but lacks randomized-controlled trial (RCT) evaluation. This paper presents a RCT protocol evaluating BBC's effect on OME resolution, hearing, speech, and QoL in children aged two to seven years. Methods: This parallel-group, 1:1, outcome assessor-blinded, individual adaptive RCT investigates whether completing the BBC intervention plus hand hygiene twice-daily at home increases OME resolution after 4-to-6 weeks in children with OME, compared to hand hygiene alone. Families (n = 250) perform their individually randomized program (BBC plus hand hygiene, or hand hygiene only) at home. The primary outcome is the difference in OME resolution rates between trial arms, assessed using tympanometry (type B to A or C1 transition) and otoscopy. Secondary outcomes include natural OME resolution, discharges from tertiary care, family satisfaction, hearing thresholds, QoL, bacterial load in the nasopharynx and on hands, cost comparison within the RCT versus standard care, and adverse events. All outcomes are measured by blinded researchers. An intention-to-treat analysis will be performed on all randomized participants. Guided by an Aboriginal Community Advisory Group, the RCT ensures culturally appropriate research whilst addressing community priorities in managing childhood ear disease. Discussion: If efficacious, BBC could reform OME treatment, reduce costs, and improve long-term hearing, speech, and QoL outcomes in some children. Its accessibility offers a globally scalable solution.

Document Type

Journal Article

Date of Publication

10-1-2025

Volume

47

Publication Title

Contemporary Clinical Trials Communications

Publisher

Elsevier

School

Kurongkurl Katitjin

Funders

Western Australian Department of Health Research Translation / Western Australian Future Health Research and Innovation Fund / Stan Perron Charitable Foundation / National Health and Medical Research Council / The Kids Research Institute Australia / Wesfarmers Centre of Vaccines and Infectious Diseases / Research Training Program

Grant Number

NHMRC Number : 2015750

Creative Commons License

Creative Commons Attribution 4.0 License
This work is licensed under a Creative Commons Attribution 4.0 License.

Comments

Rich, J. R., Dymock, M., Seppanen, E. J., Montgomery, E., Cayley, T., Veselinović, T., Bernabei, G., Lester, A., Hannigan, A., Irvine, N., Gidgup, K., Ninyette, E., Bray, S., Tran, T. T., Swift, V. M., Edmunds, M., Strobel, N., McAullay, D., Marsh, J., . . . Brennan-Jones, C. G. (2025). Evaluating the impact of the 'blow, breathe, cough’ health promotion intervention in resolving otitis media with effusion in children: An adaptive randomized-controlled trial protocol. Contemporary Clinical Trials Communications, 47, 101531. https://doi.org/10.1016/j.conctc.2025.101531

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Link to publisher version (DOI)

10.1016/j.conctc.2025.101531