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Not yet recruitingNCT06048211Updated Sep 21, 2023

Impact of the Stool Color Scale on the Detection of Neonatal Cholestasis

An observational study in Neonatal Cholestasis, sponsored by Central Hospital, Nancy, France. Not yet recruiting at 1 site in France. Open to participants aged Up to 12 Months. Per ClinicalTrials.gov, last updated 2023-09-21.

Sponsored by Central Hospital, Nancy, France · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
100
Ages
Up to 12 Months
Sex
All
01

Study 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.

Read the detailed description

The first part of the study consist in send a questionnaire to health professionnal to see their use of the stool color scale in the health book of newborn.

The second part of the study is to see the age of children with cholestasis at the date of the first consult with a specialist.

02

Conditions studied

  • Neonatal Cholestasis

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03

In context

Cholestasis

150 studies on the registry are indexed under Cholestasis; 18 are open to participants now.

This study's planned enrollment of 100 is close to the median of 95 across 36 observational studies indexed under Cholestasis.

Browse Cholestasis studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.

Browse Central Hospital, Nancy, France studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 12 Months
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • cholestasis

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Observational model
Other
Time perspective
Other
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • OtherStool color scale

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

06

What researchers measure

Primary outcomes

  1. use of stool color scale

    questionnaire

    Time frame: 4 month

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2023; primary completion for Dec 2023, 3 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 15, 2023
First posted
Sep 21, 2023
StartEst.
Sep 10, 2023
Primary completionEst.
Dec 31, 2023
CompletionEst.
Jan 30, 2024
Last update
Sep 21, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06048211
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Sponsor
First posted
Sep 21, 2023
Start date
Sep 10, 2023 (estimated)
Primary completion
Dec 31, 2023 (estimated)
Completion
Jan 30, 2024 (estimated)
Last update
Sep 21, 2023

Study contacts

Marjorie BONNETON
Contact
m.bonneton@chru-nancy.fr
+33383858585

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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