Catheters, IndwellingIMPROVENCT06616012
Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal IntensiVE Care Patients -3
A study testing Neosense umbilical catheter in people with Catheters, Indwelling and Preterm Birth, run by Neosense Technologies at 6 sites in Sweden.
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?
- Ages 0 years to 1 day
- Conditions the study is for
- Catheters, Indwelling, Preterm Birth, Compromised Health
- 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
- 50 participants
- Where
- 6 sitesSweden
- Study dates
- 14 Sep 2023to 30 Mar 2025
- 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 0 years to 1 day
- All sexes
- No healthy volunteers
- Child
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.
- 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
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- 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
6 sites in 1 country.
6 sites in 1 country
Sweden6 sites
Östra/Sahlgrenska University Hospital
Gothenburg, Halland County
Skåne University Hospital
Lund/Malmö, Skåne County
Karolinska University Hospital
Stockholm, Stockholm County
Södersjukhuset
Stockholm, Stockholm County
Uppsala University Children's Hospital
Uppsala, Uppland
Västmanalands Hospital
Västerås, Västmanland County
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
- Conditions
- Catheters, Indwelling, Preterm Birth, Compromised Health
- Being tested
- Neosense umbilical catheter
- Keywords
- neonatal, arterial oxygen tension, oxygen therapy
- Medical subject headings
- Premature Birth
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 a standard umbilical catheter
| Study group | Role | What they receive |
|---|---|---|
| Neosense Umbilical Catheter | Experimental | The Neosense umbilical catheter is used instead of the routinely used umbilical catheter Receives: Device: Neosense umbilical catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 5 days
Secondary outcomes (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 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start14 Sep 2023
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheters, IndwellingStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neosense Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Sindelar, MD, PhD, Associate professor, Principal investigator, Uppsala University Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616012
- Sponsor's protocol ID
- IMPROVE-3
- Acronym
- IMPROVE
- Status last verified
- Sep 2024
- First submitted
- 24 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. 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 -3
- ClinicalTrials.gov ID
- NCT06616012
- Acronym / sponsor ID
- IMPROVE / IMPROVE-3
- Conditions
- Catheters, Indwelling, Preterm Birth, Compromised Health
- Keywords
- neonatal, arterial oxygen tension, oxygen therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Neosense TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 27 Sep 2024 (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 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
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 catheterThe Neosense umbilical catheter is used instead of the routinely used umbilical catheter |
Who may qualify
- Ages
- 0 years to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (10 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 a standard umbilical catheter | Device | Neosense Umbilical Catheter |
Primary outcome
Clinical complications with the Neosense catheter.
Time frame: During study, up to 5 days
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.
1 secondary outcome
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 5 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Richard Sindelar, MD, PhD, Associate professor principal investigator
Uppsala University Children's Hospital
6 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, Indwelling and Preterm Birth, run by Neosense Technologies at 6 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: status not confirmed, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
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?
Clinical complications with the Neosense catheter. (time frame: During study, up to 5 days). 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 27 Sep 2024.