Correcting ear deformities in newborns using two different devices
CORRECTION OF EAR DEFORMITIES IN NEWBORNS BY MODELING, COMPARISON OF TWO PROTOCOLS
This study is testing a new silicone device against a popular one to see which works better for fixing ear deformities in newborns.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | N/A to 1 Month |
| Sex | All |
| Sponsor | University Hospital, Caen Academic / other |
| Locations | 1 site (Caen, N) |
| Trial ID | NCT06431698 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are newborns aged between 8 days and 1 month who have ear malformations.
Not a fit: Patients with total chondrocutaneous agenesis of the ear or those with polymalformative syndromes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and accessible treatment option for newborns with ear malformations.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, making this a potentially novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Caen, N
- Caen University Hospital — Caen, N, France (Recruiting)
Study contacts
- Study coordinator: Alexis VEYSSIERE
- Email: drci-secretariat@chu-caen.fr
- Phone: +33231063106
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.