CathetersIMPROVENCT03967587

Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal intensiVE Care Patients

A study testing Neosense Umbilical Catheter in people with Catheters and Oxygen Saturation, run by Neosense Technologies at 2 sites in Sweden.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The study is a non-blinded trial with one single intervention in sick newborn infants. The Neosense umbilical catheter will be used instead of the routinely used umbilical catheter on infants where the treating physician has ordered use of an umbilical catheter. Read more about this study

Who is it for?: Any age
Conditions the study is for: Catheters, Oxygen Saturation, Newborn, Infant, Disease
What is being tested?: Neosense Umbilical Catheter
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 2 sitesSweden
Study dates: 19 Nov 2020to 6 Mar 2021
Phase: Interventional
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

Who may be able to join

Sick newborn infants where the clinical routine indicates use of an umbilical catheter. At least one of the criteria below should be fulfilled:
The infant needs invasive measurement of blood pressure.
The infant needs repetitive sampling of blood.
The infant needs prolonged infusion(s) > 2 days.
The infant needs infusion of vessel irritating and potentially vessel harming solutions.
The infant is born extremely preterm (before 28+0 weeks gestational age).

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A newborn infant with severe respiratory disorder, requiring oxygen treatment (more than 40% Fraction of inspired oxygen (FiO2)).
The infant is undergoing therapeutic hypothermia following asphyxia ("oxygen deficiency at birth").
The infant has a severe infection/sepsis.
Signed informed consent form by both parents (or guardians), (if the infant has only one parent (or guardian) one informed consent is required).

Who cannot join

Gastroschisis
Omphalocele
Peritonitis
Necrotizing enterocolitis
Omphalitis

Trial locations and contacts

2 sites in 1 country.

Sweden2 sites

Karolinska University Hospital
Huddinge
Uppsala University Children's Hospital
Uppsala

Other trials in Sweden

About this study

Blood samples for blood gas analysis are collected from the patients according to the clinical routine (every 4th to 6th hour). Oxygen tension data from the Neosense measuring system, from the time points when a blood gas sample was collected, will be recorded. This data will be compared to the oxygen tension value from the blood gas sample collected at the same time point. The blood gas samples will be analysed according to clinical and laboratory routine.

The infants will remain in the study as long as the Neosense measuring system is used.

Conditions: Catheters, Oxygen Saturation, Newborn, Infant, Disease
Being tested: Neosense Umbilical Catheter
Keywords: Neonatal, Umbilical Arteries, Umbilical Veins, Oxygen Partial Pressure
Medical subject headings: Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Neosense Umbilical CatheterDevice
The Neosense umbilical catheter is used instead of the routinely used umbilical catheter

Study groups in NCT03967587
Study group	Role	What they receive
Neosense Umbilical Catheter	Experimental	Not described Receives: Device: Neosense Umbilical Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

Measurement performance of an intravascular oxygen sensor in the Neosense system.
The oxygen tension measured by the Neosense system, compared to the oxygen tension measured by a blood gas analyser.
Measured: Average of measurement comparisons done at every blood gas sample, i.e. every 4th - 6th hour during the study (up to 8 days)

Secondary outcomes (4)

Clinical complications with the Neosense catheter.
The number of occasions when the Neosense catheter had to be removed and the underlying reason. This includes all anticipated device effects as well as placing the catheter in the wrong vessel, impossible to measure blood pressure, collect blood samples and/or administer fluids.
Measured: During study, up to 8 days
Any deviations from normal procedures when inserting an umbilical catheter.
Number of attempts to place the catheter for each patient. Any accessories needed to introduce or handle the Neosense catheter.
Measured: During day 1
Number of monitor lockups or battery depletions
Timepoint for monitor lockup or battery depletion, in case of occurrence.
Measured: During study, in average 4-5 days
Usability and functionality of the Neosense monitor.
Occurence of anticipated adverse device effects for the monitor.
Measured: During study, in average 4-5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Nov 20206 Mar 2021

First posted30 May 2019
Study start19 Nov 2020
Primary completion6 Mar 2021
Study completion6 Mar 2021

Why it stopped: The clinical investigation IMPROVE has been closed after a decision by the Swedish Medical Products Agency that the trial must comply to the new European medical regulation MDR.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for CathetersStudies of the same condition, open and under way.
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: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03967587
Sponsor's protocol ID: IMPROVE
Acronym: IMPROVE
Status last verified: Jan 2022
First submitted: 10 May 2019
Last updated: 1 Feb 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
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Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal intensiVE Care Patients
ClinicalTrials.gov ID: NCT03967587
Acronym / sponsor ID: IMPROVE / IMPROVE
Conditions: Catheters, Oxygen Saturation, Newborn, Infant, Disease
Keywords: Neonatal, Umbilical Arteries, Umbilical Veins, Oxygen Partial Pressure
Study type: Interventional
Recruitment status: TerminatedReason stopped: The clinical investigation IMPROVE has been closed after a decision by the Swedish Medical Products Agency that the trial must comply to the new European medical regulation MDR.
Enrolment: 6 participants (actual)
Lead sponsor: Neosense TechnologiesIndustry (pharma, biotech, devices)
Study start: 19 Nov 2020 (actual)
Primary completion: 6 Mar 2021 (actual)
Study completion: 6 Mar 2021 (actual)
First posted: 30 May 2019 (actual)
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 infants will remain in the study as long as the Neosense measuring system is used.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Neosense Umbilical Catheter	Experimental	Device: Neosense Umbilical Catheter

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (10 listed)

Sick newborn infants where the clinical routine indicates use of an umbilical catheter. At least one of the criteria below should be fulfilled:
Signed informed consent form by both parents (or guardians), (if the infant has only one parent (or guardian) one informed consent is required).

Key exclusion criteria (5 listed)

Gastroschisis
Omphalocele
Peritonitis
Necrotizing enterocolitis
Omphalitis

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
Neosense Umbilical CatheterThe Neosense umbilical catheter is used instead of the routinely used umbilical catheter	Device	Neosense Umbilical Catheter

Primary outcome

Measurement performance of an intravascular oxygen sensor in the Neosense system.
Time frame: Average of measurement comparisons done at every blood gas sample, i.e. every 4th - 6th hour during the study (up to 8 days)
The oxygen tension measured by the Neosense system, compared to the oxygen tension measured by a blood gas analyser.

4 secondary outcomes

Clinical complications with the Neosense catheter.
Time frame: During study, up to 8 days
Any deviations from normal procedures when inserting an umbilical catheter.
Time frame: During day 1
Number of monitor lockups or battery depletions
Time frame: During study, in average 4-5 days
Usability and functionality of the Neosense monitor.
Time frame: During study, in average 4-5 days

Results and safety

The study was stopped early (reason given: The clinical investigation IMPROVE has been closed after a decision by the Swedish Medical Products Agency that the trial must comply to the new European medical regulation MDR.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
Individual participant dataSharing planned: No

Related trials for Catheters

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)

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.

Mats B Blennow, MD, Prof. principal investigator

Karolinska University Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Neosense Umbilical Catheter in people with Catheters and Oxygen Saturation, run by Neosense Technologies at 2 sites in Sweden.

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 10 inclusion and 5 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 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Sweden. 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?

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?

Measurement performance of an intravascular oxygen sensor in the Neosense system. (time frame: Average of measurement comparisons done at every blood gas sample, i.e. every 4th - 6th hour during the study (up to 8 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03967587.

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 1 Feb 2022.