Early Detection of Neonatal Shock

Impact of Advanced Hemodynamic Monitoring Clinical Trial

— Edscini  

Official title:

Early Detection of Shock in Critically Ill Newborn Infants. The Impact of Advanced Hemodynamic Monitoring

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01550198
• Other study ID #: Edscini Study 1.0
• Status: Terminated
• Start date: May 2013
• Est. completion date: July 2022

Study information

• Verified date: June 2023
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: July 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Impact of Advanced Hemodynamic Monitoring
• Shock

Intervention

Device:
• Advanced hemodynamic monitoring
Comprehensive advanced hemodynamic monitoring

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre, Department of Neonatology	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac output assessed by transpulmonary ultrasound dilution and simultaneously clinically estimated cardiac output		2 years