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NCT05367466 Clinical Trial

Risk Factors of Neonatal Thrombosis

Thrombosis Clinical Trial

Official title:
Evaluation of Acquired and Hereditary Risk Factors of Neonatal Thrombosis: Single-centre Experience

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05367466
Other study ID # 2022.03.38
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2014
Est. completion date April 10, 2022

Study information
Verified date May 2022
Source Kirikkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The incidence of symptomatic thrombosis is between 2.4 and 6.8 per 1000 neonatal intensive care unit admission while it is 5.1 per 100 000 live births. Compared to adults, the anticoagulant and fibrinolytic system of newborns is significantly different. In this study, the aim is to evaluate infants with neonatal thrombosis in our unit to characterize acquired and genetic risk factors, the laboratory work-up parameters and the diagnosis approach.

Description:

All newborn patients diagnosed with neonatal thrombosis in our NICU between 2014 and 2019; were included in the study. Patients' data: maternal and neonatal characteristics, consanguinity, need for resuscitation, Apgar scores, diagnoses, need for mechanical ventilation, sepsis, catheter placement, treatment regimens and hospital outcomes; Laboratory findings: CBC; D-dimer levels and the performed genetic test Thrombosis diagnosis was confirmed by imaging techniques such as ultrasonography (USG), echocardiography, and magnetic resonance imaging (MRI). The genotypes: Factor V (Leiden) G1691A, prothrombin G20210A, MTHFRC677T, MTHFRA1298C, PAI-SERPINE1, Factor XIII V34L mutations

Recruitment information / eligibility
Status Completed
Enrollment 11
Est. completion date April 10, 2022
Est. primary completion date December 30, 2019
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - All newborn accepted at NICU Exclusion Criteria: - No

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Kirikkale University

Outcome
Type Measure Description Time frame Safety issue
Primary Thrombosis in the neonatal period is multifactorial January 2022
Primary Hereditary thrombophilia factors also should be thought January 2022
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