Neonatal CholestasisNCT06048211
Impact of the Stool Color Scale on the Detection of Neonatal Cholestasis
An observational study of Neonatal Cholestasis, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Neonatal Cholestasis
- What is being tested?
- Stool color scale
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 10 Sep 2023to 30 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: patient under 12 month with cholestasis who consult or was hospitalized for this reason.
Who may be able to join
- cholestasis
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Stool Color Scale in the French Health Book on the Detection of Neonatal Cholestasis
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.
- Conditions
- Neonatal Cholestasis
- Being tested
- Stool color scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool color scaleOther
observationnal trial about the use of the stool color scale by the health professionnals
What is being measured
The primary outcome is the main question the study is designed to answer.
use of stool color scale
questionnaire
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start10 Sep 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal CholestasisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048211
- Sponsor's protocol ID
- 2022PI149
- Status last verified
- Sep 2023
- First submitted
- 15 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Stool Color Scale in the French Health Book on the Detection of Neonatal Cholestasis
- ClinicalTrials.gov ID
- NCT06048211
- Acronym / sponsor ID
- 2022PI149
- Conditions
- Neonatal Cholestasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 10 Sep 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- patient under 12 month with cholestasis who consult or was hospitalized for this reason.
Key inclusion criteria (1 listed)
- cholestasis
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stool color scaleobservationnal trial about the use of the stool color scale by the health professionnals | Other | – |
Primary outcome
use of stool color scale
Time frame: 4 month
questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
Related trials for Neonatal Cholestasis
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Determine the Prevalence of Exocrine Pancreatic Insufficiency (EPI) in Pediatric and Adult Participants With Alagille Syndrome After Liver Transplantation
Exocrine Pancreatic Insuficiency
RecruitingObservational study
A Study Observing the Long-term, Effectiveness and Safety of Odevixibat (Bylvay) in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment
Alagille Syndrome
RecruitingObservational study
A Study to Observe the Long-term Safety of Odevixibat in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment
Alagille Syndrome
RecruitingObservational study
Elafibranor Pregnancy Surveillance Program: A Study to Evaluate the Safety of Elafibranor During Pregnancy
Pregnancy Related
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Cholestasis, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marjorie BONNETON (+33383858585, m.bonneton@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
use of stool color scale (time frame: 4 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.