Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06150807
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-06
First Post:
2023-11-21
Brief Title:
Portal Vein Thrombosis in Neonate With Umbilical Catheter
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Frequency and Risk Factors of Portal Vein Thrombosis in Neonate With Umbilical Catheter
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to identify incidence of portal vein thrombosis after umbilical catheter and to identify the risk factor of this condition location of PVT and prognosis of PVT
Detailed Description:
The use of umbilical venous catheters UVCs in the neonatal period may be associated with severe complications including the occurrence of portal vein thrombosis PVT 1 The placement of an umbilical venous catheter UVC is a common procedure in neonatology and has multiple clinical indications driven by the need for quick and secure access for medication administration Umbilical venous catheters allow quick access for administering drugs blood products fluids and parenteral nutrition to acutely ill neonates however they are have many complications The most common complication is nosocomial sepsis ranging from 3 to 16 followed by thromboembolism and catheter malposition in the heart great vessels or portal system23 The diagnosis is made by abdominal Doppler ultrasonography In the cases with portal venous thrombosis the location extent and size of the thrombus were recorded occlusive was defined by hyperechogenic thrombus replacing the entire lumen and no-flow in color Doppler or Partial which defined by non-occlusive hyperechogenic intraluminal thrombus and persistent stream in color Doppler4 A prospective observational study of newborns who were admitted to the Neonatal intensive care Unit Assiut University Childrens Hospital neonates who had undergo UVC for any cause between 102023 to 92024 will enroll in these study with serial ultrasonography of the UVC to determine the incidence and location of thrombi in infants after umbilical catheterization
All cases included in the study will be evaluated by Birth weight gender gestational age type of catheter duration of catheter use types of infused fluids and location of the catheter tips UVC Ultrasound examinations of the liver and spleen including color Doppler imaging of the portal veins hepatic veins splenic vein and superior mesenteric vein will done in the Department of Pediatric Diagnostic Imaging by a radiologist after removal of the catheter and in case of PVT subsequent serial US will preformed until clot resolution
All cases included in the study will be evaluated by Birth weight gender gestational age type of catheter duration of catheter use types of infused fluids and location of the catheter tips UVC Ultrasound examinations of the liver and spleen including color Doppler imaging of the portal veins hepatic veins splenic vein and superior mesenteric vein will done in the Department of Pediatric Diagnostic Imaging by a radiologist after removal of the catheter and in case of PVT subsequent serial US will preformed until clot resolution
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None