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

NCT02767648 | Terminated

• 2 other identifiers: 08 030 082008
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Cholestasis

Keywords

cholestasis; neonatal; infant

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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

Secondary Outcomes (3)

• Homogenization of diagnosis and treatment of new born with the constitution and follow up of a prospective cohorte

  Up to 3 years

• 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

Study Arms (1)

cholestasis

infant suffering from cholestasis proteomic urine analysis

Other: proteomic urine analysis

Interventions

proteomic urine analysis OTHER

proteomic urine analysis

cholestasis

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

infant suffering from cholestasis

You may qualify if:

• Infant \<1 year suffering from cholestasis

You may not qualify if:

• Rejection or inability for parent to give their informed consent

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (4)

UH Bordeaux

Bordeaux, France

Location

UH Limoges

Limoges, France

Location

UH Montpellier

Montpellier, 34000, France

Location

UH Toulouse

Toulouse, 31000, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

proteomic urine analysis

MeSH Terms

Conditions

Cholestasis

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Pierre Broue, MD

  UH Toulouse

  PRINCIPAL INVESTIGATOR

• Thierry Lamireau, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Jane Languepin, MD

  UH Limoges

  PRINCIPAL INVESTIGATOR

• Sebastien Fournier-Favre, MD

  UH Monptellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2015
• First Posted: May 10, 2016
• Study Start: May 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: May 10, 2016

Record last verified: 2016-05

Locations

FR (4)