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

Neonatal Cholestasis Clinical Trial

Official title:

Impact of the Stool Color Scale in the French Health Book on the Detection of Neonatal Cholestasis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06048211
• Other study ID #: 2022PI149
• Status: Not yet recruiting
• Start date: September 10, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: September 2023
• Source: Central Hospital, Nancy, France
• Contact: Marjorie BONNETON
• Phone: +33383858585
• Email: m.bonneton[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Months

Eligibility

Inclusion Criteria:

• cholestasis Exclusion Criteria: -

Related Conditions & MeSH terms

• Cholestasis
• Neonatal Cholestasis

Intervention

Other:
• Stool color scale
observationnal trial about the use of the stool color scale by the health professionnals

Locations

Country	Name	City	State
France	CHRU Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	use of stool color scale	questionnaire	4 month