Using advanced ultrasound to diagnose ear infections in children
Utility of Advanced Ultrasound Otoscope In The Diagnosis of Acute Otitis Media
This study is testing a new ultrasound tool to see if it can help doctors better diagnose ear infections in children who need ear tube surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 0 Years to 12 Years |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06429709 on ClinicalTrials.gov |
What this trial studies
This study aims to gather ultrasound signal data and visual images using a prototype Advanced Ultrasound Otoscope for children who are scheduled for tympanostomy tube surgery. The collected data will help develop algorithms to improve the diagnosis of ear infections, specifically focusing on conditions like recurrent acute otitis media and chronic otitis media with effusion. Participants will have their ear images taken, and the presence of any infections or normal findings will be noted by the surgeon. The study ensures that no identifiable personal information is recorded, maintaining participant confidentiality.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged newborn to 12 years who are receiving their first set of pressure equalization tubes due to recurrent ear infections or related conditions.
Not a fit: Patients with cholesteatoma, tympanic membrane perforation, or those who have previously had PE tubes placed will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of diagnosing ear infections in children, leading to better treatment outcomes.
How similar studies have performed: While this approach is innovative, it builds on existing diagnostic techniques, and similar studies have shown promise in improving diagnostic accuracy for ear infections.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newborn to 12 years of age * Receiving first set of pressure equalization (PE) tubes, even if coordinated with other procedures such as adenoidectomy * Indication for surgery includes recurrent acute otitis media, chronic otitis media with effusion, Eustachian tube dysfunction, and/or hearing loss. Exclusion Criteria: * Cholesteatoma, tympanic membrane perforation, myringitis * History of PE tube placement or PE tubes currently in place.
Where this trial is running
Houston, Texas
- Texas Children's Hospital — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Yi-Chun Liu, MD — Baylor College of Medicine
- Study coordinator: Rachel Arp
- Email: rearp@texaschildrens.org
- Phone: 936-267-7707
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.