Stool Card in Biliary Atresia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-90
SponsorAssiut University
About this trial
To evaluate the effectiveness of using a stool color card as a non-invasive screening tool for the early detection of biliary atresia, with the objective of improving early diagnosis rates and facilitating timely surgical intervention.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Neonates and infants aged 1-90 days old.
Neonates and infants with direct (conjugated) hyperbilirubinemia (Conjugated hyperbilirubinemia is generally defined as a conjugated or direct bilirubin level greater than 1 mg/dL when the total bilirubin is less than 5 mg/dL or more than 20% of the total bilirubin if the total bilirubin is greater than 5 mg/dL) [12]
No contraindication for liver biopsy as considered the gold standard for diagnosis of biliary atresia e.g. coagulopathy.
Disqualifiers
None
Trial population
The study population will consist of newborn infants screened using the stool color card during the first six months of life. Participants will be recruited from pediatric outpatient clinics and neonatal follow-up units, as well as infants admitted with suspected liver disease at \[Name of Hospital/Region\]. Both healthy infants and those later diagnosed with biliary atresia will be included to evaluate the diagnostic accuracy of the stool color card.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Effectiveness of Stool Color Card in Early Detection of Biliary Atresia
Diagnostic accuracy of the stool color card for early detection of biliary atresia (BA). Accuracy will be evaluated by sensitivity (proportion of BA cases detected), specificity (proportion of healthy infants correctly identified as not having BA), positive predictive value (PPV), and negative predictive value (NPV), compared to the reference standard of final diagnosis confirmed by imaging or surgery.
Time frame
First 3 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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