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Risk Factors of Neonatal Thrombosis

Sponsor
Kırıkkale University (Other)
Overall Status
Completed
CT.gov ID
NCT05367466
Collaborator
(none)
11
Enrollment
99.3
Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    11 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Evaluation of Acquired and Hereditary Risk Factors of Neonatal Thrombosis: Single-centre Experience
    Actual Study Start Date :
    Jan 1, 2014
    Actual Primary Completion Date :
    Dec 30, 2019
    Actual Study Completion Date :
    Apr 10, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Newborn with thrombossis

    All admitted newborns in NICU during the study period

    Outcome Measures

    Primary Outcome Measures

    1. Thrombosis in the neonatal period is multifactorial [January 2022]

    2. Hereditary thrombophilia factors also should be thought [January 2022]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • All newborn accepted at NICU
    Exclusion Criteria:
    • No

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Kırıkkale University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nilufer Guzoglu, Assoc. Prof, Kırıkkale University
    ClinicalTrials.gov Identifier:
    NCT05367466
    Other Study ID Numbers:
    • 2022.03.38
    First Posted:
    May 10, 2022
    Last Update Posted:
    May 10, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nilufer Guzoglu, Assoc. Prof, Kırıkkale University
    newborn, hereditary risk factors
    Additional relevant MeSH terms:
    Thrombosis

    Study Results

    No Results Posted as of May 10, 2022