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

Not Applicable

Recruiting

• Conditions: Ear Malformation

• Registration Number: NCT06431698
• Lead Sponsor: University Hospital, Caen

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-31
• Status Verified: 2024-03
• Study First Submitted: 2024-05-22
• Study First Submitted QC: 2024-05-22
• Last Update Submitted: 2024-05-22
• Study First Posted: 2024-05-28
• Last Update Posted: 2024-05-28
• Primary Completion: 2024-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 134

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Subjective ear deformation score	baseline and 1 year after	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.

Trial Locations

Locations (1)

Caen University Hospital; 🇫🇷 Caen, N, France