Correcting ear deformities in newborns using two different devices

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a custom-made silicone device developed at Caen University Hospital compared to the commercially available EarWell™ device for correcting ear malformations in newborns. The trial aims to determine if the custom device is non-inferior to the EarWell™ device in terms of outcomes. Newborns aged between 8 days and 1 month with ear malformations will be included in the study, while those with more severe conditions or parental refusal will be excluded. The study is conducted at Caen University Hospital, focusing on innovative approaches to treat congenital ear deformities.

Why it matters

Who can join: the full rules

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

Where it's running

• Caen University Hospital
  Caen, N, France Recruiting

Study contacts

• Study coordinator: Alexis VEYSSIERE
• Email: drci-secretariat@chu-caen.fr
• Phone: +33231063106

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.