Inter-regional Cohort of Neonatal and Infant Cholestasis in the Greater Southwest Region
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 57
- 试验地点
- 4
- 主要终点
- Gathering mother epidemiologic characteristics as assessed by pregancy informations collection
研究概览
简要总结
The goal of the study is to characterize the epidemiologic data of the neonatal and infant cholestasis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant <1 year suffering from cholestasis
排除标准
- •Rejection or inability for parent to give their informed consent
结局指标
主要结局
Gathering mother epidemiologic characteristics as assessed by pregancy informations collection
时间窗: Day 1 (inclusion)
Date of child birth, course of pregnancy, occurrence of twin pregnancy, serology abnormalities, family background of liver desease, course of previous pregnancies
Gathering new born epidemiologic characteristics as assessed by birth informations collection
时间窗: Day 1 (inclusion)
Birth anamnesis, inclusion age, hepatic desease history, hemostasis workup, validated etiologic diagnosis and criteria for the diagnosis, specific and non-specific therapeutic care
Epidemiologic characteristics follow up as assessed by medical monitoring
时间窗: When children are between 12 and 18 months old
Desease evolution in the first year of life, clinical evaluation, biological evaluation, final diagnosis, complications of the sickness, existence of transplatation, death
次要结局
- Extend the study to the national french territory using the hepatology association network(Up to 3 years)
- Identification of proteomic profiles using the biologic collection gathered in the cohorte population(Up to 3 years)
- Homogenization of diagnosis and treatment of new born with the constitution and follow up of a prospective cohorte(Up to 3 years)