The Dirty Nappy Study

NCT07697872 | Recruiting

• 1 other identifier: 327150
• Study Type: observational
• Target: 5,350
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholestasis in Newborn; Biliary Atresia; Neonatal Cholestasis

Keywords

Neonatal cholestasis; Biliary atresia diagnosis; Newborn stool analysis; infant liver disease; screening; machine learning; AI; image analysis

Outcome Measures

Primary Outcomes (1)

• Sensitivity & Specificity of an Algorithm in Detecting Cholestasis

  Sensitivity: The proportion of stool images from clinically confirmed cholestatic infants that are correctly classified as positive by the algorithm, calculated as a single estimate across all evaluable images collected between Day 14 and Day 34 of life, using an independent held-out test dataset. Specificity: The proportion of stool images from clinically confirmed non-cholestatic infants that are correctly classified as negative by the algorithm, calculated as a single estimate across all evaluable images collected between Day 14 and Day 34 of life, using an independent held-out test dataset.

  Stool images collected between Day 14 and Day 34 of life; evaluation performed once clinical confirmation of cholestasis status is complete (up to 6 months of age).

Secondary Outcomes (10)

• Sensitivity & Specificity of an Algorithm in Detecting Biliary Atresia

  Stool images collected between Day 14 and Day 34 of life; evaluation performed once clinical confirmation of biliary atresia status is complete (up to 6 months of age).

• Sensitivity & Specificity of an Algorithm in Detecting Abnormal Stool Appearance (Colour and/or Texture)

  Images collected in the third week (Day 14- Day 20), fourth week (Day 21- Day 27), and fifth week (Day 28- Day 34) of life; evaluation is performed once clinical confirmation is complete (up to 6 months of age).

• Sensitivity & Specificity of an Algorithm in Detecting Biliary Atresia in Cholestatic Infants

  Data collected from children less than 6 months; evaluation is performed once clinical confirmation is complete (up to 6 months of age).

• Impact of Repeat Stool Image on Diagnostic Reclassification Among Initially Positive Cases in the 3rd Week of Life

  Repeat stool images will be collected between Day 21 and Day 27 of life for infants with an initial positive result from Day 14-20; final outcome confirmation will occur through clinical follow-up (up to 6 months of age).

• Parents / Guardians Comfort Level with Photo-Based Diagnostic Requests to Assist in the Diagnosis of Biliary Atresia

  Assessments will be completed by parents/guardians at the end of each child's participation in the study (up to 6 months of age).

Study Arms (3)

Retrospective Cholestasis Cohort

This group includes infants who were referred to a specialist paediatric liver unit for suspected cholestasis within the past 10 years. This cohort provides historical data to evaluate the machine-learning algorithm's performance using existing images and clinical outcomes. No new interventions or prospective data collection occur in this group.

Prospective Cholestasis Cohort

This group includes infants who are newly referred for cholestasis investigation to a specialist paediatric liver unit during the study period. Parents will provide stool images at 14, 21, and 28 days of life, 3 months, and 6 months using a smartphone. These images will be analysed by a machine-learning algorithm to assess whether early stool image screening can help detect cholestasis, including biliary atresia. Participants will also share feedback on their experience with this screening method. This cohort provides real-time prospective data to train and validate the algorithm.

Prospective Non-Cholestasis Cohort

This group consists of newborns born at specified hospitals who are the time of recruitment are not thought to be cholestatic. Parents will submit stool images at 14, 21, and 28 days of life, 3 months, and 6 months to provide a large dataset of normal stool images. This cohort serves as a control group, ensuring that the algorithm can distinguish between healthy and abnormal stool patterns.

Eligibility Criteria

• Age: Up to 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Recruited from hospitals enrolled in the study.

You may qualify if:

• All Arms:
• Informed Consent: Parents/guardians can give informed consent for their child's participation in the study and can understand written English.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Elixir AI: collaborator
• Birmingham Women's and Children's NHS Foundation Trust: lead

Study Sites (1)

Birmingham Women's and Children's NHS Foundation Trust

Birmingham, United Kingdom

RECRUITING

MeSH Terms

Conditions

Biliary Atresia

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: July 13, 2026
• Study Start: April 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)