Contemporary clinical trials communications · 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.
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Rich Jaimee R, Dymock Michael, Seppanen Elke J, Montgomery Elena, Cayley Tanisha, Veselinović Tamara, Bernabei Greta, Lester Anri, Hannigan Amy, Irvine Nicole, Gidgup Kerryn, Ninyette Edna, Bray Steph, Tran Tu Trang, Swift Valerie M, Edmunds Melinda, Strobel Natalie, McAullay Daniel, Marsh Julie, Tay Evelyn, Kirkham Lea-Ann S, Thornton Ruth B, Choi Robyn S M, Timms Lydia, Jackson Emily, Kuthubutheen Jafri, Richmond Peter C, Brennan-Jones Christopher G
Аннотация
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.
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.