Recruiting NCT06431698
CORRECTION OF EAR DEFORMITIES IN NEWBORNS BY MODELING, COMPARISON OF TWO PROTOCOLS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Custom-made silicone device, adjustable Earwell device.
- Who it may be relevant to
- Registry conditions: Ear Malformation. Basic parameters: up to 1 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Interventions
- Device Custom-made silicone device
Correction of deformation using the custom-made silicone device - Device adjustable Earwell device
Correction of deformation using the adjustable Earwell device
Primary outcome measures
- Subjective ear deformation score [Time frame: baseline and 1 year after]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- Caen University Hospital — Caen
Identifiers
NCT: NCT06431698 · 21-0023