Risk Factors of Neonatal Thrombosis

May 5, 2022 updated by: Nilufer Guzoglu, Kırıkkale University

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

11

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All newborns in NICU during 5 year period

Description

Inclusion Criteria:

  • All newborn accepted at NICU

Exclusion Criteria:

  • No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Newborn with thrombossis
All admitted newborns in NICU during the study period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Thrombosis in the neonatal period is multifactorial
Time Frame: January 2022
January 2022
Hereditary thrombophilia factors also should be thought
Time Frame: January 2022
January 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kırıkkale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

April 10, 2022

Study Registration Dates

First Submitted

May 5, 2022

First Submitted That Met QC Criteria

May 5, 2022

First Posted (Actual)

May 10, 2022

Study Record Updates

Last Update Posted (Actual)

May 10, 2022

Last Update Submitted That Met QC Criteria

May 5, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022.03.38

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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