Early Detection of Neonatal Shock

Terminated

• Conditions: Impact of Advanced Hemodynamic Monitoring
• Interventions: Device: Advanced hemodynamic monitoring

• Registration Number: NCT01550198
• Lead Sponsor: Radboud University Medical Center

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-07
• Study First Submitted QC: 2012-03-07
• Study First Posted: 2012-03-09
• Study Start: 2013-05
• Primary Completion: 2021-12
• Study Completion: 2022-07
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-28
• Last Update Posted: 2023-06-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Birth weight >700 grams
• Arterial catheter in place
• Central venous catheter in place
• Informed consent from parents/legal representatives

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Exclusion Criteria

• Life-threatening congenital defects
• Congenital heart defects, except patent ductus arteriosus and patent foramen ovale

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Newborns	Advanced hemodynamic monitoring	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")

Primary Outcome Measures

Name	Time	Method
Cardiac output assessed by transpulmonary ultrasound dilution and simultaneously clinically estimated cardiac output	2 years

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Centre, Department of Neonatology; 🇳🇱 Nijmegen, Netherlands