CORRECTION OF EAR DEFORMITIES IN NEWBORNS BY MODELING, COMPARISON OF TWO PROTOCOLS
ConditionEar Malformation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 1
SponsorUniversity Hospital, Caen
About this trial
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
Qualifiers
Newborn, age between 8 days and 1 month
newborn with ear malformation
Disqualifiers
Total chondrocutaneous agenesis of the ear
polymalformative syndrome
age greater than 4 weeks
parental refusal
Trial design
Treatments tested in this trial
- Custom-made silicone device
- adjustable Earwell device
Treatment groups
134 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov