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

May 9, 2016 updated by: University Hospital, Toulouse
The goal of the study is to characterize the epidemiologic data of the neonatal and infant cholestasis.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

57

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • UH Bordeaux
      • Limoges, France
        • UH Limoges
      • Montpellier, France, 34000
        • UH Montpellier
      • Toulouse, France, 31000
        • UH Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

infant suffering from cholestasis

Description

Inclusion Criteria:

  • Infant <1 year suffering from cholestasis

Exclusion Criteria:

  • Rejection or inability for parent to give their informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cholestasis
infant suffering from cholestasis proteomic urine analysis
Other: proteomic urine analysis
proteomic urine analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gathering mother epidemiologic characteristics as assessed by pregancy informations collection
Time Frame: 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
Day 1 (inclusion)
Gathering new born epidemiologic characteristics as assessed by birth informations collection
Time Frame: 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
Day 1 (inclusion)
Epidemiologic characteristics follow up as assessed by medical monitoring
Time Frame: 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
When children are between 12 and 18 months old

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Pierre Broue, MD, UH Toulouse
  • Principal Investigator: Thierry Lamireau, MD, UH Bordeaux
  • Principal Investigator: Jane Languepin, MD, UH Limoges
  • Principal Investigator: Sebastien Fournier-Favre, MD, UH Monptellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

July 10, 2015

First Submitted That Met QC Criteria

May 9, 2016

First Posted (Estimate)

May 10, 2016

Study Record Updates

Last Update Posted (Estimate)

May 10, 2016

Last Update Submitted That Met QC Criteria

May 9, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08 030 08
  • 2008 (Ministry of Health)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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