The Dirty Nappy Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 11
SponsorBirmingham Women's and Children's NHS Foundation Trust
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
Recruited from hospitals enrolled in the study.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
5,350 Participants
are grouped into 3 trial groupsGroup A: Retrospective Cholestasis Cohort
Group B: Prospective Cholestasis Cohort
Group C: Prospective Non-Cholestasis Cohort
Trial outcomes
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.
Time frame
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
1
Sensitivity & Specificity of an Algorithm in Detecting Biliary Atresia
Sensitivity: The proportion of stool images from clinically confirmed infants with biliary atresia 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 infants without biliary atresia 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.
Time frame
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).2
Sensitivity & Specificity of an Algorithm in Detecting Abnormal Stool Appearance (Colour and/or Texture)
Sensitivity: This measure is the proportion of abnormal stool images from infants that are correctly classified as positive by the algorithm. Sensitivity will be calculated separately for images collected during the third, fourth, and fifth weeks of life, yielding three distinct sensitivity values. This approach provides an independent assessment of how well the algorithm identifies true positive results, using a separate, untrained test dataset. Specificity: This measure is the proportion of normal stool images from infants that are correctly classified as negative by the algorithm. Specificity will be calculated separately for images collected during the third, fourth, and fifth weeks of life, yielding three distinct specificity values. This approach provides an independent assessment of how well the algorithm avoids false positive results, using a separate, untrained test dataset.
Time frame
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).3
Sensitivity & Specificity of an Algorithm in Detecting Biliary Atresia in Cholestatic Infants
Diagnostic accuracy of the algorithm in detecting biliary atresia among cholestatic infants, reported as sensitivity and specificity. Both measures share a common unit of measure (proportion, reported as percentage). Sensitivity: the proportion of cholestatic infants with confirmed biliary atresia whose combined stool image and supplemental clinical data are correctly classified as positive by the algorithm. Specificity: the proportion of cholestatic infants without biliary atresia whose combined stool image and supplemental clinical data are correctly classified as negative by the algorithm. Both assessed using an independent held-out test dataset not used during model training.
Time frame
Data collected from children less than 6 months; evaluation is performed once clinical confirmation is complete (up to 6 months of age).4
Impact of Repeat Stool Image on Diagnostic Reclassification Among Initially Positive Cases in the 3rd Week of Life
Among infants initially classified as positive for cholestasis / biliary atresia by the Elixir algorithm based on stool images submitted during the 3rd week of life (Day 14-20), this outcome measure evaluates the change in diagnostic classification after a repeat stool image is submitted during the subsequent window (Day 21-27). Specifically, it will assess: * The proportion of initially positive cases that are reclassified as negative upon repeat testing, and are subsequently confirmed as false positives. * The proportion of initially positive cases that remain positive upon repeat testing and are confirmed as true positives. This measure is intended to determine whether requesting a repeat stool image can reduce the false positive rate without inadvertently reclassifying true cholestatic cases as negative (i.e. false reassurance). Final classification for each infant will be confirmed by clinical diagnosis up to 6 months of age.
Time frame
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).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Birmingham Women's and Children's NHS Foundation Trust
Lead sponsor
Elixir AI
Collaborator
Source ClinicalTrials.gov