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

Primary Purpose

Catheter, Newborn, Infant, Disease, Lung Diseases

Status
Terminated
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Neosense Umbilical Catheter
Sponsored by
Neosense Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Catheter focused on measuring Neonatal, Umbilical Arteries, Oxygen Partial Pressure

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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).
  • 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).

Exclusion Criteria:

  • Gastroschisis
  • Omphalocele
  • Peritonitis
  • Necrotizing enterocolitis
  • Omphalitis
  • The infant has a severe infection/sepsis
  • 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

Sites / Locations

  • Danderyd Hospital
  • Karolinska University Hospital
  • Karolinska University Hospital
  • Södersjukhuset
  • Uppsala University Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neosense Umbilical Catheter

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Any deviations from normal procedures when inserting an umbilical catheter
Number of attempts to place the catheter for each patient.
Number of monitor lock up or battery depletions
Timepoint for monitor lock up or battery depletion, in case of occurrence
Adverse device effects of the Neosense monitor.
Occurence of anticipated adverse device effects for the monitor.
Any deviations from normal procedures when inserting an umbilical catheter.
Any accessories needed to introduce the Neosense catheter.
Any deviations from normal procedures when inserting an umbilical catheter.
Any accessories needed to handle the Neosense catheter during insertion.

Full Information

First Posted
June 14, 2022
Last Updated
September 15, 2023
Sponsor
Neosense Technologies
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1. Study Identification

Unique Protocol Identification Number
NCT05433779
Brief Title
Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal intensiVE Care Patients -2
Acronym
IMPROVE-2
Official Title
Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal intensiVE Care Patients -2
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
The clinical investigation IMPROVE-2 has been closed after a decision by the Swedish Medical Products Agency.
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
June 16, 2023 (Actual)
Study Completion Date
June 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neosense Technologies

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter, Newborn, Infant, Disease, Lung Diseases
Keywords
Neonatal, Umbilical Arteries, Oxygen Partial Pressure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neosense Umbilical Catheter
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Neosense Umbilical Catheter
Intervention Description
The Neosense umbilical catheter is used instead of the routinely used umbilical catheter
Primary Outcome Measure Information:
Title
Measurement performance (continuously) of an intravascular oxygen sensor in the Neosense system
Description
The oxygen tension measured by the Neosense system, compared to the oxygen tension measured by a blood gas analyser.
Time Frame
Measurement comparisons done at every blood gas sample, i.e. every 4th - 6th hour during the study (up to 8 days)
Secondary Outcome Measure Information:
Title
Clinical complications with the Neosense catheter.
Description
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.
Time Frame
Time Frame: During study, up to 8 days
Title
Any deviations from normal procedures when inserting an umbilical catheter
Description
Number of attempts to place the catheter for each patient.
Time Frame
During day 1
Title
Number of monitor lock up or battery depletions
Description
Timepoint for monitor lock up or battery depletion, in case of occurrence
Time Frame
During study, in average 4-5 days
Title
Adverse device effects of the Neosense monitor.
Description
Occurence of anticipated adverse device effects for the monitor.
Time Frame
During study, in average 4-5 days
Title
Any deviations from normal procedures when inserting an umbilical catheter.
Description
Any accessories needed to introduce the Neosense catheter.
Time Frame
During day 1
Title
Any deviations from normal procedures when inserting an umbilical catheter.
Description
Any accessories needed to handle the Neosense catheter during insertion.
Time Frame
During day 1

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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). 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). Exclusion Criteria: Gastroschisis Omphalocele Peritonitis Necrotizing enterocolitis Omphalitis The infant has a severe infection/sepsis 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Sindelar, MD PhD
Organizational Affiliation
Uppsala University Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danderyd Hospital
City
Danderyd
Country
Sweden
Facility Name
Karolinska University Hospital
City
Huddinge
Country
Sweden
Facility Name
Karolinska University Hospital
City
Solna
Country
Sweden
Facility Name
Södersjukhuset
City
Stockholm
Country
Sweden
Facility Name
Uppsala University Children's Hospital
City
Uppsala
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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