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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.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neosense Umbilical Catheter | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neosense Umbilical Catheter | Device | The Neosense umbilical catheter is used instead of the routinely used umbilical catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Average of measurement comparisons done at every blood gas sample, i.e. every 4th - 6th hour during the study (up to 8 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During study, up to 8 days |
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Inclusion Criteria:
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).
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mats B Blennow, MD, Prof. | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Huddinge | Sweden | ||||
| Uppsala University Children's Hospital |
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| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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. | During day 1 |
| Number of monitor lockups or battery depletions | Timepoint for monitor lockup or battery depletion, in case of occurrence. | During study, in average 4-5 days |
| Usability and functionality of the Neosense monitor. | Occurence of anticipated adverse device effects for the monitor. | During study, in average 4-5 days |
| Uppsala |
| Sweden |