Inter-regional Cohort of Neonatal and Infant Cholestasis in the Greater Southwest Region

Terminated

• Conditions: Cholestasis
• Interventions: Other: proteomic urine analysis

• Registration Number: NCT02767648
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

The goal of the study is to characterize the epidemiologic data of the neonatal and infant cholestasis.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Study First Submitted: 2015-07-10
• Status Verified: 2016-05
• Study First Submitted QC: 2016-05-09
• Last Update Submitted: 2016-05-09
• Study First Posted: 2016-05-10
• Last Update Posted: 2016-05-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Infant <1 year suffering from cholestasis

Exclusion Criteria

• Rejection or inability for parent to give their informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cholestasis	proteomic urine analysis	infant suffering from cholestasis proteomic urine analysis

Primary Outcome Measures

Name	Time	Method
Gathering mother epidemiologic characteristics as assessed by pregancy informations collection	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	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	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

Secondary Outcome Measures

Name	Time	Method
Extend the study to the national french territory using the hepatology association network	Up to 3 years	Use this study to start a national study
Identification of proteomic profiles using the biologic collection gathered in the cohorte population	Up to 3 years	Identify one or more specific proteomic profile of neonatal cholestasis
Homogenization of diagnosis and treatment of new born with the constitution and follow up of a prospective cohorte	Up to 3 years	Homogenize the care pathway of neonatal and infant cholestasis

Trial Locations

Locations (4)

UH Bordeaux; 🇫🇷 Bordeaux, France

UH Limoges; 🇫🇷 Limoges, France

UH Montpellier; 🇫🇷 Montpellier, France

UH Toulouse; 🇫🇷 Toulouse, France