The Dirty Nappy Study

Официальное название

The Dirty Nappy Study: Development and Evaluation of a Machine Learning Algorithm for the Early Detection of Cholestasis and Biliary Atresia From Parent-Provided Images of Dirty Nappies

Обзор

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.

Подробное описание

As the Study Design section only allows selection of a single time perspective, this Detailed Description box is being used to clarify that the study involves both prospective and retrospective data collection, as instructed.

This study includes two prospective arms (following newborns from birth, with and without suspected cholestasis, and collecting stool images in real time) and one retrospective arm (using historical stool images and clinical data from diagnosed cases).

Первичные конечные точки

• Sensitivity & Specificity of an Algorithm in Detecting Cholestasis [Срок оценки: 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).]

Вторичные конечные точки (10)

• Sensitivity & Specificity of an Algorithm in Detecting Biliary Atresia [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Assessments will be completed by parents/guardians at the end of each child's participation in the study (up to 6 months of age).]
• Parents / Guardians Comfort Level with Smartphone-Based Health Information Sharing, Including Photos, Videos, Audio, or Questionnaire Responses, to Assist in Medical Diagnosis or Prioritise Care [Срок оценки: Assessments will be completed by parents/guardians at the end of each child's participation in the study (up to 6 months of age).]
• Sensitivity & Specificity of the Current UK Practice of Prolonged Jaundice Screening in Detecting Cholestasis [Срок оценки: Data collected retrospectively from historical records covering a one-year period.]
• Sensitivity & Specificity of the Current UK Practice of Prolonged Jaundice Screening in Detecting Biliary Atresia [Срок оценки: Data collected retrospectively from historical records covering a one-year period; final outcome confirmation will occur through clinical follow-up (up to 6 months of age).]
• Mean Age at Time of Split Bilirubin Testing Following the Current UK Practice of Prolonged Jaundice Screening [Срок оценки: Data collected retrospectively from historical clinical records covering a one-year period.]
• Mean Age at Time of Hepatoportoenterostomy (HPE) Surgery Following the Current UK Practice of Prolonged Jaundice Screening [Срок оценки: Data collected retrospectively from historical surgical records covering a one-year period.]

Критерии участия

Критерии включения

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.

Критерии исключения

If the inclusion criteria as outlined are met, there is no exclusion criteria.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Великобритания · 1 центр

• Birmingham Women's and Children's NHS Foundation Trust — Birmingham

Идентификаторы

NCT: NCT07697872 · 327150

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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