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

University Hospital, Caen134 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

134

Conditions

Ear Malformation

Interventions

Custom-made silicone deviceDEVICE

Correction of deformation using the custom-made silicone device

adjustable Earwell deviceDEVICE

Correction of deformation using the adjustable Earwell device

Eligibility

Sex: ALLMax age: 1 Month

Medical Language ↔ Plain English

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

Locations (1)

Caen University Hospital

Caen, N, France

RECRUITING

Outcomes

Primary Outcomes

Subjective ear deformation score

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.

Time frame: baseline and 1 year after

Central Contacts

Alexis VEYSSIERE

CONTACT

+33231063106 drci-secretariat@chu-caen.fr

VEYSSIERE

CONTACT

drci-secretariat@chu-caen.fr

Data from ClinicalTrials.gov

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