Impact of Advanced Hemodynamic MonitoringEdsciniNCT01550198
Early Detection of Neonatal Shock
An observational study of Impact of Advanced Hemodynamic Monitoring, run by Radboud University Medical Center at 1 site in Netherlands.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Impact of Advanced Hemodynamic Monitoring
- What is being tested?
- Advanced hemodynamic monitoring
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2013to Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Neonates admitted to a neonatal intensive care unit
Who may be able to join
- Birth weight >700 grams
- Arterial catheter in place
- Central venous catheter in place
- Informed consent from parents/legal representatives
Who cannot join
- Life-threatening congenital defects
- Congenital heart defects, except patent ductus arteriosus and patent foramen ovale
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre, Department of Neonatology
Nijmegen
About this study
Official title: Early Detection of Shock in Critically Ill Newborn Infants. The Impact of Advanced Hemodynamic Monitoring
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
- Being tested
- Advanced hemodynamic monitoring
- Keywords
- newborn, shock, hemodynamics, cardiac output, blood pressure
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced hemodynamic monitoringDevice
Comprehensive advanced hemodynamic monitoring
| Study group | Role | What they receive |
|---|---|---|
| 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") Receives: Device: Advanced hemodynamic monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output assessed by transpulmonary ultrasound dilution and simultaneously clinically estimated cardiac output
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startMay 2013
- Primary completionDec 2021
- Study completionJul 2022
Why it stopped: Problems with availability of cardiac output monitoring system
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impact of Advanced Hemodynamic MonitoringStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Willem de Boode, MD PhD, Principal investigator, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550198
- Sponsor's protocol ID
- Edscini Study 1.0
- Acronym
- Edscini
- Status last verified
- Jun 2023
- First submitted
- 7 Mar 2012
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Shock in Critically Ill Newborn Infants. The Impact of Advanced Hemodynamic Monitoring
- ClinicalTrials.gov ID
- NCT01550198
- Acronym / sponsor ID
- Edscini / Edscini Study 1.0
- Keywords
- newborn, shock, hemodynamics, cardiac output, blood pressure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Problems with availability of cardiac output monitoring system
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2021 (actual)
- Study completion
- Jul 2022 (actual)
- First posted
- 9 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newborns | – | Device: Advanced hemodynamic monitoringCritically 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") |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Neonates admitted to a neonatal intensive care unit
Key inclusion criteria (4 listed)
- Birth weight >700 grams
- Arterial catheter in place
- Central venous catheter in place
- Informed consent from parents/legal representatives
Key exclusion criteria (2 listed)
- Life-threatening congenital defects
- Congenital heart defects, except patent ductus arteriosus and patent foramen ovale
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced hemodynamic monitoringComprehensive advanced hemodynamic monitoring | Device | Newborns |
Primary outcome
Cardiac output assessed by transpulmonary ultrasound dilution and simultaneously clinically estimated cardiac output
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Problems with availability of cardiac output monitoring system). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Willem de Boode, MD PhD principal investigator
Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Impact of Advanced Hemodynamic Monitoring, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Problems with availability of cardiac output monitoring system). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output assessed by transpulmonary ultrasound dilution and simultaneously clinically estimated cardiac output (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023; AzTrials last refreshed its copy on 4 Nov 2026.