NCT07697872 The Dirty Nappy Study

Eligibility & Interventions

Eligibility Fast-Check

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 5,350 participants in total. It began in 2025-04-01 with a primary completion date of 2026-09-30.

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: All Arms: Informed Consent: Parents/guardians can give informed consent for their child's participation in the study and can understand written English. 1. Retrospective Cholestasis Arm: All infants, of any gestation, male and female who were referred to Birmingham Liver Unit from any hospital for investigation of suspected cholestasis within the previous 10 years before the study launch. At the time of the referral to Birmingham Liver Unit the children were under the age of 6 months and the children were referred before the start date of the study. 2. Prospective Cholestasis Arm: All infants, of any gestation, male and female who were referred to Birmingham Liver Unit from any hospital for investigation of suspected cholestasis after the study launch. At the time of the referral to Birmingham Liver Unit the children were under the age of 6 months. 3. Prospective Non-Cholestasis Arm All infants, of any gestation, male and female \& aged less than 28 days, not thought to be cholestatic at the time of recruitment \& with the birth registered at any of the participating hospital trusts. Exclusion Criteria: If the inclusion criteria as outlined are met, there is no exclusion criteria.

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