Anomalies of the Auricle in Normally Present Term Newborns From 0 to 6 Weeks of Age (NCT07419061) | Clinical Trial Compass
CompletedNot Applicable
Anomalies of the Auricle in Normally Present Term Newborns From 0 to 6 Weeks of Age
France99 participantsStarted 2022-01-04
Plain-language summary
There are two types of anomalies that occur during the embryonic period in the auricle: malformations and deformities.
Deformities are characterized by a normal chondrocutaneous auricle, without excess or deficiency of skin or cartilage, but with an abnormal structure caused by external forces such as poor positioning in the womb or during childbirth. The helix and antihelix are often affected, followed by the concha.
Malformations are characterized by a partial absence of skin or cartilage resulting from constriction or underdevelopment during the embryonic period.
In the literature, there is increasing interest in auricle anomalies. Numerous studies describe auricle anomalies, observe their prevalence in newborns, and note their spontaneous or increasingly innovative corrective techniques.
It is difficult to draw conclusions and to project the need to correct these anomalies depending on whether they are minor or affect half the ears of newborn children.
Who can participate
Age range
1 Day – 6 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Newborns aged 0 to 6 weeks
* Present in the Maternity and Postpartum Unit of the Rouen University Hospital.
* Whose legal representatives do not object to the study
Exclusion Criteria:
* A premature newborn (before 37 weeks of gestation)
* Low birth weight (less than 2500g)
* Another organ pathology or a complex malformation syndrome discovered at birth
* Birth under anonymity
* Legal representative(s) deprived of liberty by an administrative or judicial decision or placed under legal protection/guardianship or curatorship
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.