Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the effectiveness of using a stool color card as a non-invasive screening tool for the early detection of biliary atresia, with the objective of improving early diagnosis rates and facilitating timely surgical intervention.
Biliary atresia (BA) is a rare but life-threatening liver disorder that affects infants, characterized by the progressive inflammation and fibrosis of the bile ducts, leading to biliary obstruction [1].
Early diagnosis and intervention are crucial - ideally before 60 days of age - as BA is a leading cause of liver transplantation in children if not diagnosed and treated promptly [2]. The traditional method of diagnosis involves the identification of clinical signs like jaundice and abnormal liver function tests, but this approach can delay the diagnosis, leading to irreversible liver damage. As a result, early detection is essential to improve outcomes and prevent the need for a liver transplant [3].
The stool color card (SCC) is a diagnostic tool that has gained significant attention in recent years as a non-invasive method for the early detection of biliary atresia [4]. Newborns with biliary atresia typically exhibit pale stools due to a lack of bile secretion [5].
The stool color card provides a simple way for parents or healthcare professionals to monitor changes in the stool color in newborns, providing an early indicator of potential biliary atresia [6,7]. The card features a range of colors that correspond to the different stages of stool color, allowing for easy comparison and identification of abnormal stool [8-11].
Despite the availability of SCCs, their effectiveness in routine screening programs remains understudied. There is a need to evaluate the utility of SCCs in improving early diagnosis rates of BA.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of Stool Color Card in Early Detection of Biliary Atresia | Diagnostic accuracy of the stool color card for early detection of biliary atresia (BA). Accuracy will be evaluated by sensitivity (proportion of BA cases detected), specificity (proportion of healthy infants correctly identified as not having BA), positive predictive value (PPV), and negative predictive value (NPV), compared to the reference standard of final diagnosis confirmed by imaging or surgery. | First 3 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
1 - Infants diagnosed with biliary atresia or other cholestatic liver diseases prior to enrollment.
2-Infants aged more than 90 days 3-Neonates and infants with indirect hyperbilirubinemia. 4-Those with contraindication to do liver biopsy
Not provided
Not provided
The study population will consist of newborn infants screened using the stool color card during the first six months of life. Participants will be recruited from pediatric outpatient clinics and neonatal follow-up units, as well as infants admitted with suspected liver disease at [Name of Hospital/Region]. Both healthy infants and those later diagnosed with biliary atresia will be included to evaluate the diagnostic accuracy of the stool color card.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Hassan Hamed, Principal Investigator | Contact | +201123046138 | Ahmed.17289840@med.aun.edu.eg |
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25681196 | Result | Gu YH, Yokoyama K, Mizuta K, Tsuchioka T, Kudo T, Sasaki H, Nio M, Tang J, Ohkubo T, Matsui A. Stool color card screening for early detection of biliary atresia and long-term native liver survival: a 19-year cohort study in Japan. J Pediatr. 2015 Apr;166(4):897-902.e1. doi: 10.1016/j.jpeds.2014.12.063. Epub 2015 Feb 11. | |
| 24244109 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001656 | Biliary Atresia |
| ID | Term |
|---|---|
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D004065 | Digestive System Abnormalities |
Not provided
Not provided
Not provided
Not provided
Not provided
| Feldman AG, Sokol RJ. Neonatal Cholestasis. Neoreviews. 2013 Feb 1;14(2):10.1542/neo.14-2-e63. doi: 10.1542/neo.14-2-e63. |
| 34842600 | Result | Madadi-Sanjani O, Kuebler JF, Uecker M, Pfister ED, Baumann U, Kunze-Hullmann B, Blaser J, Buck T, Petersen C. Province-Wide Stool Color Card Screening for Biliary Atresia in Lower-Saxony: Experiences with Passive Distribution Strategies and Results. Int J Neonatal Screen. 2021 Nov 4;7(4):75. doi: 10.3390/ijns7040075. |
| 38994513 | Result | Alam R, Nahid KL, Faruk MO, Rasna EH, Rukunuzzaman M. Use of stool color card as screening tool for biliary atresia in resource-constraint country. Gastroenterol Hepatol Bed Bench. 2024;17(2):146-150. doi: 10.22037/ghfbb.v17i2.2931. |
| 33664005 | Result | El-Shabrawi MH, Baroudy SR, Hassanin FS, Farag AE. A pilot study of the value of a stool color card as a diagnostic tool for extrahepatic biliary atresia at a single tertiary referral center in a low/middle income country. Arab J Gastroenterol. 2021 Mar;22(1):61-65. doi: 10.1016/j.ajg.2020.12.004. Epub 2021 Mar 2. |
| 35207269 | Result | Schreiber RA, Harpavat S, Hulscher JBF, Wildhaber BE. Biliary Atresia in 2021: Epidemiology, Screening and Public Policy. J Clin Med. 2022 Feb 14;11(4):999. doi: 10.3390/jcm11040999. |
| 34817690 | Result | Rabbani T, Guthery SL, Himes R, Shneider BL, Harpavat S. Newborn Screening for Biliary Atresia: a Review of Current Methods. Curr Gastroenterol Rep. 2021 Nov 24;23(12):28. doi: 10.1007/s11894-021-00825-2. |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |