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Early Detection of Neonatal Shock (Edscini)

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. Read our disclaimer for details. Identifier: NCT01550198
Recruitment Status : Suspended (Problems with availability of cardiac output monitoring system)
First Posted : March 9, 2012
Last Update Posted : April 7, 2020
Information provided by (Responsible Party):
Radboud University

Brief Summary:
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 or disease Intervention/treatment
Impact of Advanced Hemodynamic Monitoring Device: Advanced hemodynamic monitoring

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Detection of Shock in Critically Ill Newborn Infants. The Impact of Advanced Hemodynamic Monitoring
Study Start Date : May 2013
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Group/Cohort Intervention/treatment
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

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

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT01550198

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Radboud University Nijmegen Medical Centre, Department of Neonatology
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University
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Principal Investigator: Willem de Boode, MD PhD Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands
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Responsible Party: Radboud University Identifier: NCT01550198    
Other Study ID Numbers: Edscini Study 1.0
First Posted: March 9, 2012    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Keywords provided by Radboud University:
cardiac output
blood pressure
Additional relevant MeSH terms:
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Pathologic Processes