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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

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

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

Detailed Summary:
Sponsor: University Hospital, Toulouse

Current Primary Outcome:

  • 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
  • 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
  • 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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
  • 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


Original Secondary Outcome: Same as current

Information By: University Hospital, Toulouse

Dates:
Date Received: July 10, 2015
Date Started: May 2010
Date Completion:
Last Updated: May 9, 2016
Last Verified: May 2016