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Neonatal cholestasis (NC) is described as an early-life defect in bile production or flow that causes the liver to retain biliary substances. Persistent Neonatal Jaundice (PNJ) is the presence of variable degrees of jaundice, choluria and hypocholic or acholic stools for more than 10 days during early months of life. The rate of neonatal cholestasis is estimated to be 1 per 2,500 live births worldwide.
In Egypt, about 20.4% of full-term newborns develop jaundice yearly. Extrahepatic cholestasis(EHC) and intrahepatic cholestasis(IHC) are the two main causes of persistent neonatal jaundice. This division is according to the presence or absence of extrahepatic obstruction to bile flow. Biliary atresia(BA) and idiopathic neonatal hepatitis(INH) are the most frequent etiologies for EHC and IHC respectively.
It is critical to identify the underlying cause of PNJ in order to start the right surgical or medicinal treatment. Early surgical referral is necessary in biliary atresia(BA) to increase success rates. In the case of treatable metabolic diseases, a prompt diagnosis justifies prompt, targeted therapy and a better prognosis.
Despite the development of new diagnostic means and advances in imaging techniques, non-invasive biomarkers and genomic studies, a liver biopsy done at the right time is still an important tool to evaluate and diagnose patients with cholestasis, as it will help to decide the etiology, the prognosis and eventually the treatment of the patient.
The evaluation of liver biopsies in infantile cholestasis disorders is crucial as the histologic features of many of these disorders may overlap and vary with age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neonates | Experimental | Neonates with persistent neonatal jaundice underwent liver biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liver biopsy | Diagnostic Test | surgical biopsy from liver |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Identification of the key histopathological features in liver biopsy | Identification of the key histopathological features in liver biopsy that aid in differentiation intra-hepatic and extra-hepatic causes of persistent neonatal jaundice (PNJ). | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of significance of liver biopsy as a diagnostic tool | Evaluation of significance of liver biopsy as a diagnostic tool with clinical and laboratory findings in detection of persistent neonatal jaundice (PNJ) causes. | baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nourhan H Fouad, MBBCh | Contact | +201229788587 | nourhannasr97@aun.edu.eg | |
| Abeer M Refaiy, M.D. | Contact | +20118449977 | abeer_refaiy@aun.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Moemen M Hafez, M.D. | Faculty of Medicine, Assiut University, Assiut, Egypt | Study Director |
| Abeer M Refaiy, M.D. | Faculty of Medicine, Assiut University, Assiut, Egypt | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16700389 | Background | Mansour E, Eissa AN, Nofal LM, Kharboush I, Reda AA. Morbidity and mortality of low-birth-weight infants in Egypt. East Mediterr Health J. 2005 Jul;11(4):723-31. | |
| 27429428 | Background | Fawaz R, Baumann U, Ekong U, Fischler B, Hadzic N, Mack CL, McLin VA, Molleston JP, Neimark E, Ng VL, Karpen SJ. Guideline for the Evaluation of Cholestatic Jaundice in Infants: Joint Recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr. 2017 Jan;64(1):154-168. doi: 10.1097/MPG.0000000000001334. |
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| ID | Term |
|---|---|
| D007567 | Jaundice, Neonatal |
| ID | Term |
|---|---|
| D051556 | Hyperbilirubinemia, Neonatal |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006932 | Hyperbilirubinemia |
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| 38008855 | Background | Ali KM, Zalata KR, Barakat T, Elzeiny SM. Pathologic approach to Neonatal cholestasis with a simple scoring system for biliary atresia. Virchows Arch. 2024 Jan;484(1):93-102. doi: 10.1007/s00428-023-03704-5. Epub 2023 Nov 27. |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |