Early Detection of Neonatal Shock | NCT01550198

Studies
Early Detection of Neonatal Shock

NCT01550198

Sponsor

Radboud University Medical Center

Status

Terminated

Last Update Posted

Jun 29, 2023Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Impact of Advanced Hemodynamic Monitoring

Interventions

Advanced hemodynamic monitoring

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Problems with availability of cardiac output monitoring system

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Dec 2021Actual

Completion Date

Jul 2022Actual

First Submitted Date

Mar 7, 2012

First Submission Date that Met QC Criteria

Mar 7, 2012

First Posted Date

Mar 9, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 28, 2023

Last Update Posted Date

Jun 29, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Advanced hemodynamic monitoring	Device	Comprehensive advanced hemodynamic monitoring	Newborns

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cardiac output assessed by transpulmonary ultrasound dilution and simultaneously clinically estimated cardiac output		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Neonates admitted to a neonatal intensive care unit

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Willem de Boode, MD PhD	Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radboud University Nijmegen Medical Centre, Department of Neonatology		Nijmegen			Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D012769	Shock

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided