Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 9:16 PM
Study NCT ID:
NCT07419061
Status:
COMPLETED
Last Update Posted:
2026-02-18
First Post:
2026-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anomalies of the Auricle in Normally Present Term Newborns From 0 to 6 Weeks of Age
Sponsor:
University Hospital, Rouen
Organization:
Study Overview
Official Title:
Anomalies of the Auricle: Number and Identification in Normally Present Term Newborns From 0 to 6 Weeks of Age, a Prospective Observational Study
Status:
COMPLETED
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LAPONI
Brief 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.
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.
Detailed Description:
Previous studies have been conducted primarily in America and Asia. It remains difficult to extrapolate these results to European populations, which do not necessarily have the same prevalence as Asian populations, for example. Indeed, one might question the significant differences found between certain studies, depending on their geographical location. Many Asian studies report 55.2% or 58% of abnormalities of the external ear, while some American studies find only 1.7% or 6% of auricle abnormalities in newborns. What about the European population, and especially the French population, which encompasses diverse origins? An additional point to analyze is the self-correction of these anomalies. Indeed, here too, numerous studies diverge on the percentage of anomalies that self-correct, ranging from 32% to 85% self-correction within one year. Conversely, some studies report an increase in certain anomalies at one year, such as protruding ears, which increase from 0.4% at birth to 5.5% at one year in the study by Matsuo et al., assuming the baby's position as the cause of this acquired deformity. The study by Zhao et al. also highlighted the increased prevalence of protruding ears between 0 and 1 month.
It appears necessary to conduct an observational study in France to determine the prevalence of auricle anomalies according to the patient's origins.
It appears necessary to conduct an observational study in France to determine the prevalence of auricle anomalies according to the patient's origins.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2021-A02596-35 | OTHER | ANSM | View |