CORRECTION OF EAR DEFORMITIES IN NEWBORNS BY MODELING, COMPARISON OF TWO PROTOCOLS
Recruiting
N/A
Interventional Study
Ear Malformation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- Up to 1 Month
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 134 (estimated)
- Sponsor
- University Hospital, Caen · Other
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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
Trial Locations
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Eligibility Criteria
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
Contacts