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Recruiting NCT06431698
CORRECTION OF EAR DEFORMITIES IN NEWBORNS BY MODELING, COMPARISON OF TWO PROTOCOLS
Trial Parameters
Condition Ear Malformation
Sponsor University Hospital, Caen
Study Type INTERVENTIONAL
Phase N/A
Enrollment 134
Sex ALL
Min Age N/A
Max Age 1 Month
Start Date 2023-07-31
Completion 2024-07-31
Interventions
Custom-made silicone deviceadjustable Earwell device
Brief Summary
Evaluation of the non-inferiority of the custom-made device developed in the maxillofacial surgery department of Caen University Hospital compared to the device from the EarWell™ group
Eligibility Criteria
Inclusion Criteria: * Newborn, age between 8 days and 1 month * newborn with ear malformation Exclusion Criteria: * Total chondrocutaneous agenesis of the ear * polymalformative syndrome * age greater than 4 weeks * parental refusal