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Early Detection of Neonatal Shock (Edscini)

This study is currently recruiting participants.
Verified October 2016 by Radboud University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01550198
First Posted: March 9, 2012
Last Update Posted: October 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Radboud University
  Purpose
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

Condition Intervention
Impact of Advanced Hemodynamic Monitoring Device: Advanced hemodynamic monitoring

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Detection of Shock in Critically Ill Newborn Infants. The Impact of Advanced Hemodynamic Monitoring

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Cardiac output assessed by transpulmonary ultrasound dilution and simultaneously clinically estimated cardiac output [ Time Frame: 2 years ]

Estimated Enrollment: 70
Study Start Date: May 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neonates admitted to a neonatal intensive care unit
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01550198


Contacts
Contact: Willem de Boode, MD PhD +31 24 3614430 willem.deboode@radboudumc.nl

Locations
Netherlands
Radboud University Nijmegen Medical Centre, Department of Neonatology Recruiting
Nijmegen, Netherlands
Principal Investigator: Willem de Boode, MD PhD         
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Willem de Boode, MD PhD Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands
  More Information

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01550198     History of Changes
Other Study ID Numbers: Edscini Study 1.0
First Submitted: March 7, 2012
First Posted: March 9, 2012
Last Update Posted: October 13, 2016
Last Verified: October 2016

Keywords provided by Radboud University:
newborn
shock
hemodynamics
cardiac output
blood pressure