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Early Detection of Neonatal Shock

NCT ID: NCT01550198

Last Updated: 2023-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2022-07-31

Brief Summary

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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

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Detailed Description

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Conditions

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Impact of Advanced Hemodynamic Monitoring

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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")

Advanced hemodynamic monitoring

Intervention Type DEVICE

Comprehensive advanced hemodynamic monitoring

Interventions

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Advanced hemodynamic monitoring

Comprehensive advanced hemodynamic monitoring

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Willem de Boode, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands

Locations

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Radboud University Nijmegen Medical Centre, Department of Neonatology

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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Edscini Study 1.0

Identifier Type: -

Identifier Source: org_study_id

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