Cholestasis in Newborn

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Review clinical trials related to Cholestasis in Newborn. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

The Dirty Nappy Study

This observational study evaluates whether a machine-learning algorithm, a computer program that learns patterns from data, can accurately diagnose cholestasis in newborns. Cholestasis refers to reduced or blocked bile flow from the liver, which can lead to liver damage. A severe form of cholestasis is biliary atresia, a condition where the bile ducts are damaged or absent, requiring early treatment to prevent long-term harm. The study involves infants from birth, both healthy and those potentially affected by cholestasis, recruited from four UK hospitals. It addresses two primary aims: * Accuracy of Diagnosis: Can the machine-learning algorithm accurately identify cholestasis and biliary atresia using parent-provided stool images? This will be assessed by measuring sensitivity (the ability to correctly detect true cases) and specificity (the ability to correctly identify infants without the condition). * Feasibility of Screening: Is using parent-provided images a feasible and acceptable screening method for early detection? To evaluate these aims, researchers will compare two groups: * Infants with abnormal stool images who are subsequently diagnosed with cholestasis or biliary atresia. * Infants with normal stool images who do not develop biliary atresia. This comparison will help determine the algorithm's ability to distinguish between infants with and without these conditions. Parents will: * Take smartphone photos of their baby's dirty diapers at 14, 21, and 28 days of age. * Upload the images for analysis by the algorithm. * Provide feedback on their experience with this screening process. The study seeks to determine if parent-submitted stool images can serve as a practical early screening tool for cholestasis, potentially enabling faster diagnosis and improved outcomes for affected infants.

Participants needed: 5,350
Trial details
Age: Up to 11Biological sex: AllType: ObservationalSponsor: Birmingham Women's and Children's NHS Foundation TrustUpdated: Jul 13, 2026Locations: 1
Eligibility criteria

Prospective Non-Cholestasis Arm All infants, of any gestation, male and female &...

Status: Recruiting

The Use of Near-Infrared Fluorescence Cholangiography With Indocyanine Green (ICG) in the Work Up of Neonatal Cholestasis

In infants that present with findings concerning for biliary atresia, along with other cholestatic work up which is standard, they will receive a one-time intravenous (IV) dose of Indocyanine Green (ICG). The infant's diapers will subsequently be examined for presence of the ICG, and if present, suggests bile flow. This was described as 97% accurate for assessing biliary patency and we would like to perform a similar study to assess biliary patency in the work up of neonatal cholestasis.

Participants needed: 15
Trial details
Phase: Early Phase 1Age: 2-4Biological sex: AllType: InterventionalSponsor: University of Alabama at BirminghamUpdated: Feb 18, 2026Locations: 1
Eligibility criteria

Infants admitted to the hospital (no matter their age, sex, race/ethnicity) who...

Infants that a hepatologist has not deemed to warrant inpatient admission for wo... [+4]