跳至主要内容
临床试验/NCT02505360
NCT02505360Unknown不适用

Comparaison Biochimique et Histologique Des Cartilages Nasal et Auriculaire Chez le fœtus et le Nouveau-né Porteur de Fente Labiale

University Hospital, Caen2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
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

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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