Comparison of Two Treatment Devices for Correcting Ear Deformities in Newborns

What this Trial Is About

This research aims to compare the effectiveness of two devices used to correct ear deformities in newborns. The study evaluates whether a custom-made silicone device developed by the maxillofacial surgery department at Caen University Hospital is not inferior to the adjustable Earwell device, commonly used for this purpose. The trial focuses on newborns with ear malformations and seeks to provide evidence for treatment options in this early stage of life. Participants are randomly assigned to one of two groups one group receives correction using the adjustable Earwell device, and the other group receives correction using the custom-made silicone device. Both devices are applied to reshape the ear, and the study monitors the correction process over time. The treatment period and specific application details are managed according to established protocols for each device. During the study, participants will be assessed for ear deformation at the start and one year after treatment using a subjective ear deformation score. Researchers will conduct evaluations to monitor the progress and outcomes of the ear correction. The total duration of participation includes the treatment period followed by a one-year follow-up to measure long-term results. Safety and adherence to the treatment protocols will be observed throughout the study.

CORRECTION OF EAR DEFORMITIES IN NEWBORNS BY MODELING, COMPARISON OF TWO PROTOCOLS