An interventional study of Liver biopsy in Neonatal Cholestasis and Neonatal Jaundice, sponsored by Assiut University. Not yet recruiting. Open to participants aged 1 Month to 1 Year. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by Assiut University · Not applicable, Interventional, and Diagnostic
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.
110 studies on the registry are indexed under Jaundice, Neonatal; 28 are open to participants now.
This study's planned enrollment of 50 is below the median of 150 across 78 interventional studies indexed under Jaundice, Neonatal.
Browse Jaundice, Neonatal studies →Assiut University is the lead sponsor of 5,079 studies on the registry; 2,177 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neonates with persistent neonatal jaundice underwent liver biopsy
Diagnostic Test: Liver biopsy
surgical biopsy from liver
Also known as: Liver wedge biopsy, Liver core biopsy, Liver incisional biopsy
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).
Time frame: baseline
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.
Time frame: baseline
No study locations are listed for this record.
Start is estimated for Nov 2024; primary completion for Nov 2025, 12 months later.
Of 35 non-industry interventional studies with no phase under Jaundice, Neonatal, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 21. This study's planned 12 months is close to that.
Counting every sponsor, half of 45 studies reached it within 11 months; a quarter within 5 and three quarters within 21.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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