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

Cholestasis Clinical Trial

— CHOLESTASE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02767648
• Other study ID #: 08 030 08
• Secondary ID: 2008
• Status: Terminated
• Phase: N/A
• First received: July 10, 2015
• Last updated: May 9, 2016
• Start date: May 2010
• Est. completion date: October 2013

Study information

• Verified date: May 2016
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 57
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

Inclusion Criteria:

• Infant <1 year suffering from cholestasis

Exclusion Criteria:

• Rejection or inability for parent to give their informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cholestasis

Intervention

Other:
• proteomic urine analysis
proteomic urine analysis

Locations

Country	Name	City	State
France	UH Bordeaux	Bordeaux
France	UH Limoges	Limoges
France	UH Montpellier	Montpellier
France	UH Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gathering mother epidemiologic characteristics as assessed by pregancy informations collection	Date of child birth, course of pregnancy, occurrence of twin pregnancy, serology abnormalities, family background of liver desease, course of previous pregnancies	Day 1 (inclusion)	No
Primary	Gathering new born epidemiologic characteristics as assessed by birth informations collection	Birth anamnesis, inclusion age, hepatic desease history, hemostasis workup, validated etiologic diagnosis and criteria for the diagnosis, specific and non-specific therapeutic care	Day 1 (inclusion)	No
Primary	Epidemiologic characteristics follow up as assessed by medical monitoring	Desease evolution in the first year of life, clinical evaluation, biological evaluation, final diagnosis, complications of the sickness, existence of transplatation, death	When children are between 12 and 18 months old	No
Secondary	Homogenization of diagnosis and treatment of new born with the constitution and follow up of a prospective cohorte	Homogenize the care pathway of neonatal and infant cholestasis	Up to 3 years	No
Secondary	Extend the study to the national french territory using the hepatology association network	Use this study to start a national study	Up to 3 years	No
Secondary	Identification of proteomic profiles using the biologic collection gathered in the cohorte population	Identify one or more specific proteomic profile of neonatal cholestasis	Up to 3 years	No