Comparaison Biochimique et Histologique Des Cartilages Nasal et Auriculaire Chez le fœtus et le Nouveau-né Porteur de Fente Labiale
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Measurements of concentration of hyaluronic acid as well as in type 1 collagen and 3
研究概览
简要总结
We seek to compare biochemically and histologically the nasal cartilage and ear in the newborn cleft lip and slot carrier in order to improve the quality of care and patient comfort after surgery of cheilorhinoplasty which is the primary treatment slots .
The concentration of hyaluronic acid as well as in type 1 collagen and 3 are assayed by immunohistochemistry and study of mRNA and then they are compared according to the type of cartilage.
This comparison is done on nasal cartilage samples and atrial newborns holders of cleft lip and operated in the neonatal period.
Given the difficulty and constraint of time it takes to reach the 20 subjects of our study , we will also add to our population the stillborn babies before 25SA and newborns who die before the age of 28 days and having had an autopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants aged 0 to 5 weeks with an isolated cleft lip and palate, that is to say non-syndromic, and that will be operated for cheilorhinoplasty neonatal, whose parents have read and understood the document Information and accepted and signed informed consent,
- •Children born without life before 25SA and whose parents have read and understood the Information and accepted and signed informed consent for diagnostic purposes permission to autopsy and scientific purposes and / or therapeutic.
- •Newborns who died before 28 days of life and whose parents have read and understood the Information and accepted and signed informed consent for diagnostic purposes permission to autopsy and scientific purposes and / or therapeutic.
- •Patients And relatives of patients who received clear information and having signed an informed consent,
- •Patients Benefiting from a health insurance plan
排除标准
- •Patient with no lip slots ( bike palate only or other Tessier slot ) )
- •Patient having slots syndromic cleft lip
- •Patient whose parents refuse entry into the study.
- •Children born without life before 25SA
- •Newborns who died after 28 days of life
研究组 & 干预措施
nasal and ear cartilage taken from the newborn
to compare biochemical and histological characteristics of both nasal and ear cartilage taken from the newborn at the time of surgical time cheilorhinoplasty
干预措施: Measurements of concentration of hyaluronic acid as well as in type 1 collagen and 3 (Other)
结局指标
主要结局
Measurements of concentration of hyaluronic acid as well as in type 1 collagen and 3
时间窗: Baseline
次要结局
未报告次要终点