Abnormalities of the Auricle of the EarLAPONINCT07419061
Anomalies of the Auricle in Normally Present Term Newborns From 0 to 6 Weeks of Age
An observational study of Abnormalities of the Auricle of the Ear, run by University Hospital, Rouen at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 6 weeks
- Conditions the study is for
- Abnormalities of the Auricle of the Ear
- What is being tested?
- Evaluation of the prevalence of auricle anomalies in newborns
- How many people
- 99 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jan 2022to 31 Mar 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 6 weeks
- All sexes
- No healthy volunteers
- Child
Study population: population of newborns aged 0 to 6 weeks with abnormalities of the auricle of the ear
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
University hospital of Rouen, Service d'ORL et Chirurgie cervico-faciale
Rouen, 76031
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Abnormalities of the Auricle of the Ear
- Being tested
- Evaluation of the prevalence of auricle anomalies in newborns
- Keywords
- full-term newborns with normal growth charts, aged 0 to 6 weeks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the prevalence of auricle anomalies in newbornsDiagnostic test
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (9)
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
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start4 Jan 2022
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormalities of the Auricle of the EarStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlotte PREVOTEAU CP PREVOTEAU, Doctor, Study director, University hospital of Rouen, Service d'ORL et Chirurgie cervico-facialeMaelle MC CHIR, (interne), Principal investigator, University hospital of Rouen, Service d'ORL et Chirurgie cervico-faciale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419061
- Sponsor's protocol ID
- 2021/0305/OB
- Other IDs
- 2021-A02596-35
- Acronym
- LAPONI
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07419061
- Acronym / sponsor ID
- LAPONI / 2021/0305/OB
- Conditions
- Abnormalities of the Auricle of the Ear
- Keywords
- full-term newborns with normal growth charts, aged 0 to 6 weeks
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 1 day to 6 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- population of newborns aged 0 to 6 weeks with abnormalities of the auricle of the ear
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of the prevalence of auricle anomalies in newbornsAprès avoir recueilli toutes les données des patients de l'étude, la première série de photographies est analysée de façon subjective par un médecin ORL | Diagnostic test | – |
Primary outcome
PREVALENCE OF EAR AURIALS
Time frame: 1 day
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.
9 secondary outcomes
IDENTIFICATION AND CATEGORIZATION OF EAR ANOMALIES (DEFORMITY)
Time frame: 1 day
IDENTIFICATION AND CATEGORIZATION OF EAR ANOMALIES (MALFORMATION)
Time frame: 1 day
Categorization of the prevalence of observed anomalies according to sex
Time frame: 1 day
Categorization of the prevalence of observed anomalies according to ethnic origin (Caucasian, African, Asian).
Time frame: 1 day
PREVALENCE OF EAR AURIALS AT 12 MONTHS
Time frame: 12 months
IDENTIFICATION AND CATEGORIZATION OF EAR ANOMALIES (DEFORMITY) AT 12 MONTHS
Time frame: 12 months
IDENTIFICATION AND CATEGORIZATION OF EAR ANOMALIES (MALFORMATION) AT 12 MONTHS
Time frame: 12 months
Categorization of the prevalence of observed anomalies according to sex at 12 months
Time frame: 12 months
Categorization of the prevalence of observed anomalies according to ethnic origin (Caucasian, African, Asian) at 12 months.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte PREVOTEAU CP PREVOTEAU, Doctor study director
University hospital of Rouen, Service d'ORL et Chirurgie cervico-faciale
Maelle MC CHIR, (interne) principal investigator
University hospital of Rouen, Service d'ORL et Chirurgie cervico-faciale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abnormalities of the Auricle of the Ear, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PREVALENCE OF EAR AURIALS (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.