Early Detection of Neonatal Shock (Edscini)

June 28, 2023 updated by: Radboud University Medical Center

Early Detection of Shock in Critically Ill Newborn Infants. The Impact of Advanced Hemodynamic Monitoring

The purpose of this study is to evaluate the hypothesis that advanced hemodynamic monitoring results in an earlier detection of circulatory failure in newborn infants

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nijmegen, Netherlands
        • Radboud University Nijmegen Medical Centre, Department of Neonatology

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Neonates admitted to a neonatal intensive care unit

Description

Inclusion Criteria:

  • Birth weight >700 grams
  • Arterial catheter in place
  • Central venous catheter in place
  • Informed consent from parents/legal representatives

Exclusion Criteria:

  • Life-threatening congenital defects
  • Congenital heart defects, except patent ductus arteriosus and patent foramen ovale

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
Intervention / Treatment
Newborns
Critically ill newborns admitted to level III neonatal intensive care unit of a university hospital, who will be monitored using transpulmonary ultrasound dilution ("advanced hemodynamic monitoring")
Device: Advanced hemodynamic monitoring
Comprehensive advanced hemodynamic monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiac output assessed by transpulmonary ultrasound dilution and simultaneously clinically estimated cardiac output
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Willem de Boode, MD PhD, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands

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

May 1, 2013

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

March 7, 2012

First Submitted That Met QC Criteria

March 7, 2012

First Posted (Estimated)

March 9, 2012

Study Record Updates

Last Update Posted (Actual)

June 29, 2023

Last Update Submitted That Met QC Criteria

June 28, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Edscini Study 1.0

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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