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Efficacy of a non-invasive middle ear aeration device in children with recurrent otitis media: A randomized

Tristan Tham1, Lauren Rahman1, Peter Costantino1

  • 1Department of Otolaryngology - Head and Neck Surgery, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New York, USA.

Contemporary Clinical Trials Communications
|October 16, 2018
PubMed

Insights

This study evaluates the EarPopper device (EP) for reducing acute otitis media (AOM) in children. Results will show if this non-invasive device can decrease AOM episodes in kids with recurrent ear infections.

Area of Science:

  • Pediatric Otolaryngology
  • Clinical Trials
  • Medical Device Efficacy

Background:

  • Acute otitis media (AOM) significantly impacts children's health.
  • Current preventive measures for AOM in children are limited beyond vaccinations.
  • Recurrent AOM poses a substantial burden on pediatric patients and healthcare systems.

Purpose of the Study:

  • To assess the efficacy of the EarPopper device (EP) in reducing AOM incidence in children with recurrent infections.
  • To investigate the impact of the EP on time to AOM, antibiotic use, and quality of life.
  • To provide evidence for a non-invasive intervention for managing pediatric recurrent AOM.

Main Methods:

  • Randomized controlled trial comparing an intervention group using the EP with an observational control group.
  • Inclusion criteria: children aged 4-11 with a history of recurrent AOM.
  • Primary endpoint: incidence of AOM. Secondary endpoints include time to AOM, antibiotic use, and quality of life (OMO-22 Form).

Main Results:

  • Study is a randomized controlled trial evaluating the EarPopper device for recurrent AOM in children.
  • The primary outcome is the incidence of AOM in the intervention and control groups.
  • Secondary outcomes include time to AOM, antibiotic use, and quality of life measures.

Conclusions:

  • The EarPopper device is being evaluated as a novel, non-invasive method to manage recurrent AOM in children.
  • Findings will inform clinical practice regarding the use of middle ear aeration devices.
  • This trial aims to establish the EP's effectiveness in reducing AOM episodes and improving pediatric health outcomes.

Keywords:
Acute otitis mediaOtitis media

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