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Anomalies of the Auricle in Normally Present Term Newborns From 0 to 6 Weeks of Age

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07419061
Acronym
LAPONI
Enrollment
99
Registered
2026-02-18
Start date
2022-01-04
Completion date
2024-03-31
Last updated
2026-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abnormalities of the Auricle of the Ear

Keywords

full-term newborns with normal growth charts, aged 0 to 6 weeks

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.

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.

Interventions

DIAGNOSTIC_TESTEvaluation of the prevalence of auricle anomalies in newborns

Après avoir recueilli toutes les données des patients de l'étude, la première série de photographies est analysée de façon subjective par un médecin ORL

Sponsors

University Hospital, Rouen
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 6 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PREVALENCE OF EAR AURIALS1 dayAfter collecting all the patient data for the study, the first set of photographs is subjectively analyzed by an ENT specialist to determine the prevalence of auricle anomalies in normographic, full-term newborns from 0 to 6 weeks of age according to the patient's origins. This first set of photographs allows the newborns' ears to be classified as follows: * 0: no abnormality * 1: abnormality present The prevalence of ear abnormalities can then be calculated.

Secondary

MeasureTime frameDescription
IDENTIFICATION AND CATEGORIZATION OF EAR ANOMALIES (DEFORMITY)1 dayThe ears of newborns with an anomaly will be subjectively analyzed by an ENT specialist, and each ear will be categorized as a deformity if the anomaly falls into one of the following categories: * Protruding ear * Cup-shaped ears * Stahl ear * Crusted conchal ear * Helical ring deformity * Lidding deformity * Lop ear
IDENTIFICATION AND CATEGORIZATION OF EAR ANOMALIES (MALFORMATION)1 dayThe ears of newborns with an anomaly will be subjectively analyzed by an ENT specialist, and each ear will be categorized as a malformation if the anomaly falls into one of the following categories: * Cryptotia * Microtia * Anotia
Categorization of the prevalence of observed anomalies according to sex1 dayThe calculation of the prevalence of each category of ear abnormalities will be carried out according to the patient's sex.
Categorization of the prevalence of observed anomalies according to ethnic origin (Caucasian, African, Asian).1 dayThe calculation of the prevalence of each category of ear abnormalities will be carried out according to ethnic origin (Caucasian, African, Asian).
PREVALENCE OF EAR AURIALS AT 12 MONTHS12 monthsDescription: After collecting all the patient data for the study, the first set of photographs is subjectively analyzed by an ENT specialist to determine the prevalence of auricle anomalies in normographic, full-term newborns from 0 to 6 weeks of age according to the patient's origins. This first set of photographs allows the newborns' ears to be classified as follows: - 0: no abnormality - 1: abnormality present The prevalence of ear abnormalities can then be calculated. Time Frame: 1 day
IDENTIFICATION AND CATEGORIZATION OF EAR ANOMALIES (DEFORMITY) AT 12 MONTHS12 monthsThe ears of newborns with an anomaly will be subjectively analyzed by an ENT specialist, and each ear will be categorized as a deformity if the anomaly falls into one of the following categories: * Protruding ear * Cup-shaped ears * Stahl ear * Crusted conchal ear * Helical ring deformity * Lidding deformity * Lop ear
IDENTIFICATION AND CATEGORIZATION OF EAR ANOMALIES (MALFORMATION) AT 12 MONTHS12 monthsThe ears of newborns with an anomaly will be subjectively analyzed by an ENT specialist, and each ear will be categorized as a malformation if the anomaly falls into one of the following categories: * Cryptotia * Microtia * Anotia
Categorization of the prevalence of observed anomalies according to sex at 12 months12 monthsThe calculation of the prevalence of each category of ear abnormalities will be carried out according to the patient's sex.
Categorization of the prevalence of observed anomalies according to ethnic origin (Caucasian, African, Asian) at 12 months.12 monthsThe calculation of the prevalence of each category of ear abnormalities will be carried out according to ethnic origin (Caucasian, African, Asian).

Countries

France

Contacts

STUDY_DIRECTORCharlotte PREVOTEAU CP PREVOTEAU, Doctor

University hospital of Rouen, Service d'ORL et Chirurgie cervico-faciale

PRINCIPAL_INVESTIGATORMaelle MC CHIR, (interne)

University hospital of Rouen, Service d'ORL et Chirurgie cervico-faciale

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026