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

Caen University Hospital

Status: Enrolling

Conditions: Ear Malformation

Treatments: Device: Custom-made silicone device; Device: adjustable Earwell device

Study type: Interventional

Funder types: Other

Identifiers

NCT06431698

21-0023 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Enrollment: 134 estimated patients

Sex: All

Ages: Under 1 month old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

Control group

Active Comparator group

Description:

Correction of deformation using the adjustable Earwell device

Treatment:

Device: adjustable Earwell device

Intervention group

Experimental group

Description:

Correction of deformation using the custom-made silicone device

Treatment:

Device: Custom-made silicone device