CORRECTION OF EAR DEFORMITIES IN NEWBORNS BY MODELING, COMPARISON OF TWO PROTOCOLS
NCT ID: NCT06431698
Last Updated: 2024-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
134 participants
INTERVENTIONAL
2023-07-31
2025-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control group
Correction of deformation using the adjustable Earwell device
adjustable Earwell device
Correction of deformation using the adjustable Earwell device
Intervention group
Correction of deformation using the custom-made silicone device
Custom-made silicone device
Correction of deformation using the custom-made silicone device
Interventions
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Custom-made silicone device
Correction of deformation using the custom-made silicone device
adjustable Earwell device
Correction of deformation using the adjustable Earwell device
Eligibility Criteria
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Inclusion Criteria
* newborn with ear malformation
Exclusion Criteria
* polymalformative syndrome
* age greater than 4 weeks
* parental refusal
1 Month
ALL
No
Sponsors
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University Hospital, Caen
OTHER
Responsible Party
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Locations
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Caen University Hospital
Caen, N, France
Countries
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Central Contacts
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Facility Contacts
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Alexis VEYSSIERE, MD
Role: primary
Other Identifiers
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21-0023
Identifier Type: -
Identifier Source: org_study_id
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