Early Detection of Neonatal Shock (Edscini)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Radboud University
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
First received: March 7, 2012
Last updated: December 9, 2015
Last verified: December 2015
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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: May 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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


Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550198

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

Radboud University Nijmegen Medical Centre, Department of Neonatology Recruiting
Nijmegen, Netherlands
Principal Investigator: Willem de Boode, MD PhD         
Sponsors and Collaborators
Radboud University
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 
Study First Received: March 7, 2012
Last Updated: December 9, 2015
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Radboud University:
cardiac output
blood pressure

ClinicalTrials.gov processed this record on May 26, 2016