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Early Detection of Neonatal Shock (Edscini)

This study is not yet open for participant recruitment.
Verified October 2012 by Radboud University
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01550198
First received: March 7, 2012
Last updated: November 1, 2012
Last verified: October 2012
History of Changes
  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:

MedlinePlus related topics: Shock
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01550198

Contacts
Contact: Willem de Boode, MD PhD +31 24 3614430 W.deBoode@cukz.umcn.nl

Locations
Netherlands
Radboud University Nijmegen Medical Centre, Department of Neonatology Not yet 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

No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01550198     History of Changes
Other Study ID Numbers: Edscini Study 1.0
Study First Received: March 7, 2012
Last Updated: November 1, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

Additional relevant MeSH terms:
Shock
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013