NCT06048211

Brief Summary

The stool color scale was set in 2018 in the health books of French children. The study aim is to see if the scale is usefull for healthcare professionals and if this scale has advanced the detection of neonatal cholestasis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2023

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

4 months

First QC Date

September 15, 2023

Last Update Submit

September 15, 2023

Conditions

Neonatal Cholestasis

Outcome Measures

Primary Outcomes (1)

  • use of stool color scale

    questionnaire

    4 month

Interventions

Stool color scaleOTHER

observationnal trial about the use of the stool color scale by the health professionnals

Eligibility Criteria

AgeUp to 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

patient under 12 month with cholestasis who consult or was hospitalized for this reason.

You may qualify if:

  • cholestasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Nancy

Nancy, France

Location

Central Study Contacts

Marjorie BONNETON

CONTACT

+33383858585m.bonneton@chru-nancy.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2023

First Posted

September 21, 2023

Study Start

September 10, 2023

Primary Completion

December 31, 2023

Study Completion

January 30, 2024

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations

FR(1)