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

Anomalies of the Auricle: Number and Identification in Normally Present Term Newborns From 0 to 6 Weeks of Age, a Prospective Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Abnormalities of the Auricle of the Ear
• Intervention / Treatment: Diagnostic test: Evaluation of the prevalence of auricle anomalies in newborns

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.

• Study Type: Observational
• Enrollment (Actual): 99

Contacts and Locations

Study Locations

• France
  • Rouen, France, 76031
    • University hospital of Rouen, Service d'ORL et Chirurgie cervico-faciale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

population of newborns aged 0 to 6 weeks with abnormalities of the auricle of the ear

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PREVALENCE OF EAR AURIALS	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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IDENTIFICATION AND CATEGORIZATION OF EAR ANOMALIES (DEFORMITY)	The 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	1 day
IDENTIFICATION AND CATEGORIZATION OF EAR ANOMALIES (MALFORMATION)	The 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	1 day
Categorization of the prevalence of observed anomalies according to sex	The calculation of the prevalence of each category of ear abnormalities will be carried out according to the patient's sex.	1 day
Categorization of the prevalence of observed anomalies according to ethnic origin (Caucasian, African, Asian).	The calculation of the prevalence of each category of ear abnormalities will be carried out according to ethnic origin (Caucasian, African, Asian).	1 day
PREVALENCE OF EAR AURIALS AT 12 MONTHS	Description: 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	12 months
IDENTIFICATION AND CATEGORIZATION OF EAR ANOMALIES (DEFORMITY) AT 12 MONTHS	The 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	12 months
IDENTIFICATION AND CATEGORIZATION OF EAR ANOMALIES (MALFORMATION) AT 12 MONTHS	The 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	12 months
Categorization of the prevalence of observed anomalies according to sex at 12 months	The calculation of the prevalence of each category of ear abnormalities will be carried out according to the patient's sex.	12 months
Categorization of the prevalence of observed anomalies according to ethnic origin (Caucasian, African, Asian) at 12 months.	The calculation of the prevalence of each category of ear abnormalities will be carried out according to ethnic origin (Caucasian, African, Asian).	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Study Director: Charlotte PREVOTEAU CP PREVOTEAU, Doctor, University hospital of Rouen, Service d'ORL et Chirurgie cervico-faciale; Principal Investigator: Maelle MC CHIR, (interne), University hospital of Rouen, Service d'ORL et Chirurgie cervico-faciale

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2022
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: full-term newborns with normal growth charts, aged 0 to 6 weeks
• Other Study ID Numbers: 2021/0305/OB; 2021-A02596-35 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No