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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02767648

Acronym

CHOLESTASE

Enrollment

Registered

2016-05-10

Start date

2010-05-31

Completion date

2013-10-31

Last updated

2016-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholestasis

Keywords

cholestasis, neonatal, infant

Brief summary

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

Interventions

OTHERproteomic urine analysis

proteomic urine analysis

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 1 Years

Healthy volunteers

Inclusion criteria

* Infant \<1 year suffering from cholestasis

Exclusion criteria

* Rejection or inability for parent to give their informed consent

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026