Anomalies of the Auricle: Number and Identification in Normally Present Term Newborns From 0 to 6 Weeks of Age, a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- PREVALENCE OF EAR AURIALS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 6 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
PREVALENCE OF EAR AURIALS
时间窗: 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.
次要结局
- IDENTIFICATION AND CATEGORIZATION OF EAR ANOMALIES (DEFORMITY)(1 day)
- IDENTIFICATION AND CATEGORIZATION OF EAR ANOMALIES (MALFORMATION)(1 day)
- Categorization of the prevalence of observed anomalies according to sex(1 day)
- Categorization of the prevalence of observed anomalies according to ethnic origin (Caucasian, African, Asian).(1 day)
- PREVALENCE OF EAR AURIALS AT 12 MONTHS(12 months)
- IDENTIFICATION AND CATEGORIZATION OF EAR ANOMALIES (DEFORMITY) AT 12 MONTHS(12 months)
- IDENTIFICATION AND CATEGORIZATION OF EAR ANOMALIES (MALFORMATION) AT 12 MONTHS(12 months)
- Categorization of the prevalence of observed anomalies according to sex at 12 months(12 months)
- Categorization of the prevalence of observed anomalies according to ethnic origin (Caucasian, African, Asian) at 12 months.(12 months)