Portal Vein Thrombosis in Neonate With Umbilical Catheter

NCT ID: NCT06150807

Last Updated: 2023-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-20

Study Completion Date

2025-01-30

Brief Summary

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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

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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 system(2,3) 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 Doppler.(4) A prospective observational study of newborns, who were admitted to the Neonatal intensive care Unit Assiut University Children's Hospital ,neonates who had undergo UVC for any cause between 10/2023 to 9/2024 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 U/S will preformed until clot resolution.

Conditions

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Portal Vein Thrombosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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ultrasound and doppler

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* the study population: all neonates with UVC, who will admitted to the Neonatal intensive care Unit Assiut University Children's Hospital had undergo UVC for any cause between 10/2023 to 9/2024 limited to diagnosis established in neonates \<28-day chronological age.

Exclusion Criteria

* Neonate who has PVT but not had UVC before .
Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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esraa mostafa ahmed

MA Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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esraa mostafa

Role: CONTACT

Phone: 01092686005

Email: [email protected]

References

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Salimi M. Comparison of beta-adrenoceptor blocking properties of sotalol, oxprenolol, propranolol and pindolol on rabbit intestinal smooth muscle. Pharmacology. 1975;13(5):441-7. doi: 10.1159/000136936.

Reference Type BACKGROUND
PMID: 1802 (View on PubMed)

Other Identifiers

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portal vein thrombosis

Identifier Type: -

Identifier Source: org_study_id