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Early Detection of Neonatal Shock (Edscini)

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ClinicalTrials.gov Identifier: NCT01550198
Recruitment Status : Suspended (Problems with availability of cardiac output monitoring system)
First Posted : March 9, 2012
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Study Design

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 : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

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

Eligibility Criteria

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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


Locations
Netherlands
Radboud University Nijmegen Medical Centre, Department of Neonatology
Nijmegen, Netherlands
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 Posted: March 9, 2012    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017

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