ClinicaliQ Trial Snapshot
- The Dirty Nappy Study — Recruiting • Gastroenterology • NCT07697872.
- What is being tested: A machine-learning algorithm designed to automatically detect cholestasis (reduced or blocked bile flow) in newborns by analyzing patterns in clinical data, aiming to improve diagnostic accuracy over current methods.
- Patient eligibility overview: The study involves newborn infants suspected of having or at risk for cholestasis, with enrollment likely based on clinical presentation or biochemical markers suggestive of impaired bile flow.
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- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
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What This Trial Is Studying
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…
Eligibility Snapshot
- : 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.