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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-11', 'studyFirstSubmitDate': '2026-02-11', 'studyFirstSubmitQcDate': '2026-02-11', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PREVALENCE OF EAR AURIALS', 'timeFrame': '1 day', '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.\n\nThis first set of photographs allows the newborns' ears to be classified as follows:\n\n* 0: no abnormality\n* 1: abnormality present The prevalence of ear abnormalities can then be calculated."}], 'secondaryOutcomes': [{'measure': 'IDENTIFICATION AND CATEGORIZATION OF EAR ANOMALIES (DEFORMITY)', 'timeFrame': '1 day', 'description': '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:\n\n* Protruding ear\n* Cup-shaped ears\n* Stahl ear\n* Crusted conchal ear\n* Helical ring deformity\n* Lidding deformity\n* Lop ear'}, {'measure': 'IDENTIFICATION AND CATEGORIZATION OF EAR ANOMALIES (MALFORMATION)', 'timeFrame': '1 day', 'description': '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:\n\n* Cryptotia\n* Microtia\n* Anotia'}, {'measure': 'Categorization of the prevalence of observed anomalies according to sex', 'timeFrame': '1 day', 'description': "The calculation of the prevalence of each category of ear abnormalities will be carried out according to the patient's sex."}, {'measure': 'Categorization of the prevalence of observed anomalies according to ethnic origin (Caucasian, African, Asian).', 'timeFrame': '1 day', 'description': 'The calculation of the prevalence of each category of ear abnormalities will be carried out according to ethnic origin (Caucasian, African, Asian).'}, {'measure': 'PREVALENCE OF EAR AURIALS AT 12 MONTHS', 'timeFrame': '12 months', 'description': "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.\n\nTime Frame: 1 day"}, {'measure': 'IDENTIFICATION AND CATEGORIZATION OF EAR ANOMALIES (DEFORMITY) AT 12 MONTHS', 'timeFrame': '12 months', 'description': '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:\n\n* Protruding ear\n* Cup-shaped ears\n* Stahl ear\n* Crusted conchal ear\n* Helical ring deformity\n* Lidding deformity\n* Lop ear'}, {'measure': 'IDENTIFICATION AND CATEGORIZATION OF EAR ANOMALIES (MALFORMATION) AT 12 MONTHS', 'timeFrame': '12 months', 'description': '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:\n\n* Cryptotia\n* Microtia\n* Anotia'}, {'measure': 'Categorization of the prevalence of observed anomalies according to sex at 12 months', 'timeFrame': '12 months', 'description': "The calculation of the prevalence of each category of ear abnormalities will be carried out according to the patient's sex."}, {'measure': 'Categorization of the prevalence of observed anomalies according to ethnic origin (Caucasian, African, Asian) at 12 months.', 'timeFrame': '12 months', 'description': 'The calculation of the prevalence of each category of ear abnormalities will be carried out according to ethnic origin (Caucasian, African, Asian).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['full-term newborns with normal growth charts, aged 0 to 6 weeks'], 'conditions': ['Abnormalities of the Auricle of the Ear']}, 'descriptionModule': {'briefSummary': 'There are two types of anomalies that occur during the embryonic period in the auricle: malformations and deformities.\n\nDeformities 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.\n\nMalformations are characterized by a partial absence of skin or cartilage resulting from constriction or underdevelopment during the embryonic period.\n\nIn 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.\n\nIt 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.', 'detailedDescription': "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.\n\nIt appears necessary to conduct an observational study in France to determine the prevalence of auricle anomalies according to the patient's origins."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Weeks', 'minimumAge': '1 Day', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'population of newborns aged 0 to 6 weeks with abnormalities of the auricle of the ear', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newborns aged 0 to 6 weeks\n* Present in the Maternity and Postpartum Unit of the Rouen University Hospital.\n* Whose legal representatives do not object to the study\n\nExclusion Criteria:\n\n* A premature newborn (before 37 weeks of gestation)\n* Low birth weight (less than 2500g)\n* Another organ pathology or a complex malformation syndrome discovered at birth\n* Birth under anonymity\n* Legal representative(s) deprived of liberty by an administrative or judicial decision or placed under legal protection/guardianship or curatorship'}, 'identificationModule': {'nctId': 'NCT07419061', 'acronym': 'LAPONI', 'briefTitle': 'Anomalies of the Auricle in Normally Present Term Newborns From 0 to 6 Weeks of Age', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'Anomalies of the Auricle: Number and Identification in Normally Present Term Newborns From 0 to 6 Weeks of Age, a Prospective Observational Study', 'orgStudyIdInfo': {'id': '2021/0305/OB'}, 'secondaryIdInfos': [{'id': '2021-A02596-35', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Evaluation of the prevalence of auricle anomalies in newborns', 'type': 'DIAGNOSTIC_TEST', 'description': "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"}]}, 'contactsLocationsModule': {'locations': [{'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': "University hospital of Rouen, Service d'ORL et Chirurgie cervico-faciale", 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'overallOfficials': [{'name': 'Charlotte PREVOTEAU CP PREVOTEAU, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': "University hospital of Rouen, Service d'ORL et Chirurgie cervico-faciale"}, {'name': 'Maelle MC CHIR, (interne)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "University hospital of Rouen, Service d'ORL et Chirurgie cervico-faciale"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}