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CatheterIMPROVE-2NCT05433779

Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal intensiVE Care Patients -2

A study testing Neosense Umbilical Catheter in people with Catheter and Newborn, Infant, Disease, run by Neosense Technologies at 5 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
Catheter, Newborn, Infant, Disease, Lung Diseases
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
8 participants
Where
5 sitesSweden
Study dates
15 Dec 2022to 16 Jun 2023
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).
Show all 11Show fewer
  • 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.
  • Also:
  • 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
  • The infant has a severe infection/sepsis
Show all 10Show fewer
  • Expected MRI investigation within the 7 first days after birth
  • The infants birth weight is below 750 g
  • The infant is born before week 25+0
  • Local vascular compromise in lower limbs or buttocks area, or portal venous hypertension

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Sweden5 sites

  • Danderyd Hospital

    Danderyd

  • Karolinska University Hospital

    Huddinge

  • Karolinska University Hospital

    Solna

  • Södersjukhuset

    Stockholm

  • Uppsala University Children's Hospital

    Uppsala

Other trials in Sweden

About this study

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. The catheter will be connected to the Neosense monitor/measuring unit.

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

Being tested
Neosense Umbilical Catheter
Keywords
Neonatal, Umbilical Arteries, Oxygen Partial Pressure
Medical subject headings
Disease, Lung Diseases

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 NCT05433779
Study groupRoleWhat they receive
Neosense Umbilical CatheterExperimentalNot described
Receives: Device: Neosense Umbilical Catheter

What is being measured

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

  1. Measurement performance (continuously) 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: Measurement comparisons done at every blood gas sample, i.e. every 4th - 6th hour during the study (up to 8 days)

Secondary outcomes (6)

  1. 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: Time Frame: During study, up to 8 days

  2. Any deviations from normal procedures when inserting an umbilical catheter

    Number of attempts to place the catheter for each patient.

    Measured: During day 1

  3. Number of monitor lock up or battery depletions

    Timepoint for monitor lock up or battery depletion, in case of occurrence

    Measured: During study, in average 4-5 days

  4. Adverse device effects of the Neosense monitor.

    Occurence of anticipated adverse device effects for the monitor.

    Measured: During study, in average 4-5 days

  5. Any deviations from normal procedures when inserting an umbilical catheter.

    Any accessories needed to introduce the Neosense catheter.

    Measured: During day 1

  6. Any deviations from normal procedures when inserting an umbilical catheter.

    Any accessories needed to handle the Neosense catheter during insertion.

    Measured: During day 1

Timeline

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

  1. First posted27 Jun 2022
  2. Study start15 Dec 2022
  3. Primary completion16 Jun 2023
  4. Study completion16 Jun 2023

Why it stopped: The clinical investigation IMPROVE-2 has been closed after a decision by the Swedish Medical Products Agency.

Resources

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
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05433779
Sponsor's protocol ID
IMPROVE-2
Acronym
IMPROVE-2
Status last verified
Sep 2023
First submitted
14 Jun 2022
Last updated
21 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Neosense Umbilical Catheter in people with Catheter and Newborn, Infant, Disease, run by Neosense Technologies at 5 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 11 inclusion and 10 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 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

The study was stopped early (reason given: The clinical investigation IMPROVE-2 has been closed after a decision by the Swedish Medical Products Agency.). 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?

Measurement performance (continuously) of an intravascular oxygen sensor in the Neosense system (time frame: 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 NCT05433779.

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 21 Sep 2023.

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