An interventional study of Assigning of a digital otoscope to the families in the intervention group in Acute Otitis Media and Otitis Media, sponsored by Turku University Hospital. Recruiting at 2 sites in Finland. Open to participants aged 12 Months to 47 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Turku University Hospital · Not applicable, Interventional, and Diagnostic
Acute otitis media (AOM) is the most common bacterial infection in young children and a major contributor to healthcare utilization and costs. Diagnosis relies on otoscopy and identification of tympanic membrane (TM) bulging, yet physician-performed otoscopy has variable diagnostic accuracy and depends heavily on clinical expertise.
Digital otoscopy combined with artificial intelligence (AI)-based image analysis has demonstrated high diagnostic accuracy in previous studies. In a recent study by our group, digital otoscopy with an automated neural network classifier reliably ruled out otitis media in children.
The PARENT-EAR randomized controlled pilot trial aims to evaluate whether parent-performed digital otoscopy at home, combined with retrospective AI analysis of captured TM images, can reduce physician visits due to suspicion of AOM. The study also assesses feasibility, diagnostic accuracy of parents after training, and potential effects on antibiotic use and healthcare utilization.
Methods and outcomes The PARENT-EAR trial is a randomized controlled pilot trial conducted at Vaasa Central Hospital and Turku University Hospital. Recruitment will occur between September and December 2026 (extended if necessary), with follow-up ending May 31, 2027 (5-9 months per participant).
Children aged 12 to 47 months with at least one AOM episode in the past 12 months will be randomized 1:1 using permuted block randomization. Exclusion criteria include tympanostomy tubes, tympanic membrane perforation, middle ear effusion at recruitment, immunosuppression, previously diagnosed hearing loss or anatomical abnormalities predisposing to AOM, and otoscopy experience of the parent.
Intervention group:
Parents receive a digital otoscope (The Ear Puffin by Sibbo Medical Devices, MDR EU Class I device) and training on TM image interpretation. They complete a TM image classification quiz before and after the training. During follow-up, parents perform home otoscopy when suspecting AOM, capture TM images/videos, interpret findings, and record symptoms in a diary. If AOM is suspected or the child appears ill, medical evaluation is instructed.
Control group:
Standard care without home otoscopy. Parents complete the same symptom diary and seek care according to usual practice.
Statistical analyses will compare outcomes between groups. AI-based TM classification will be compared against expert panel evaluation.
This is a pilot study with a target sample size of 20 children per arm, limited by device availability.
Ethical aspects, data collection and handling The study will be conducted in accordance with the Declaration of Helsinki. Written informed consent will be obtained from all parents after provision of oral and written information. Participation is voluntary, and families may withdraw at any time. Investigators may discontinue participation if deemed in the child's best interest.
The digital otoscope is a CE-marked Class I medical device used solely for visual inspection of the tympanic membrane. Pneumatic pumps are not provided. Potential risks include minor ear canal abrasions or discomfort; serious adverse events are considered rare. Any adverse events will be managed according to standard clinical practice and reported to relevant authorities when required. The study is investigator-initiated. The device manufacturer provides the otoscopes but has no role in study design, data access, or analysis.
Data will be collected via paper symptom diaries, monthly REDCap questionnaires (University of Turku), and national electronic health records (Kanta). TM images and videos will be securely stored and imported into a research database with relevant metadata.
All data will be handled in accordance with the EU General Data Protection Regulation (GDPR 2016/679). Study data will be pseudonymized and identified only by study ID numbers. The key linking personal identifiers to study IDs will be stored separately and securely. Paper diaries will be destroyed after digitalization. Consent includes permission to access health records and to use collected images and data for scientific purposes. Results will be published in peer-reviewed journals and as part of a doctoral thesis.
241 studies on the registry are indexed under Otitis Media; 32 are open to participants now.
This study's planned enrollment of 40 is below the median of 165 across 174 interventional studies indexed under Otitis Media.
Browse Otitis Media studies →Turku University Hospital is the lead sponsor of 287 studies on the registry; 67 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intervention group to receive the digital otoscope
Device: Assigning of a digital otoscope to the families in the intervention group
Control group with no intervention
Parents receive a digital otoscope (The Ear Puffin by Sibbo Medical Devices, MDR EU Class I device) and training on TM image interpretation. They complete a TM image classification quiz before and after the training. During follow-up, parents perform home otoscopy when suspecting AOM, capture TM images/videos, interpret findings, and record symptoms in a diary. If AOM is suspected or the child appears ill, medical evaluation is instructed.
Number of physician visits due to suspected AOM
Number of physician visits due to suspected AOM
Time frame: 5 to 9 months, depending on date of recruitment
Agreement between parent interpretation, AI classifier, and expert gold standard
Parent's interpretation of the tympanic membrane image is retrospectively compared to the expert's gold standard and classification by an artificial intelligence classifier
Time frame: 5 to 9 months, depending on date of recruitment
Antibiotic prescription rates
Antibiotic prescription rates for AOM in both arms
Time frame: 5 to 9 months, depending on date of recruitment
Adverse events related to otoscopy
Adverse events, such as abrasion, related to otoscopy in the experimental group
Time frame: 5 to 9 months, depending on date of recruitment
AOM-related complications
AOM-related complications, such as mastoiditis, in both arms
Time frame: 5 to 9 months, depending on date of recruitment
Daycare absence
Child's absence from daycare due to suspected AOM
Time frame: 5 to 9 months, depending on date of recruitment
Parental work absenteeism
Parental work absenteeism due to suspected AOM
Time frame: 5 to 9 months, depending on date of recruitment
Parental satisfaction on a visual analog scale (VAS)
Parental satisfaction in the experimental group of AOM management with parent-led digital otoscopy
Time frame: 5 to 9 months, depending on date of recruitment
Plan to share: Yes — Deidentified participant data will be made available upon reasonable request from the corresponding author.
Supporting information: Study protocol
Time frame: Study protocol will be published as supplementary material alongside the study manuscript alongside publication.
Access criteria: Deidentified participant data will be made available to fellow researchers upon reasonable request from the corresponding author.
Started Sep 2026 (actual). Primary completion is estimated for May 2027, 8 months after the start.
Of 36 non-industry interventional studies with no phase under Otitis Media, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 64. This study's planned 8 months is below that.
Counting every sponsor, half of 45 studies reached it within 38 months; a quarter within 13 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
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