Early Detection of Neonatal Shock (Edscini)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Radboud University
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01550198
First received: March 7, 2012
Last updated: June 4, 2013
Last verified: May 2013
  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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: May 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (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

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
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

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 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: June 4, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

ClinicalTrials.gov processed this record on October 29, 2014