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

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ClinicalTrials.gov Identifier: NCT03967587
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : January 26, 2021
Sponsor:
Information provided by (Responsible Party):
Neosense Technologies

Study Description
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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.


Condition or disease Intervention/treatment Phase
Catheters Oxygen Saturation Newborn, Infant, Disease Device: Neosense Umbilical Catheter Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal intensiVE Care Patients
Actual Study Start Date : November 19, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Neosense Umbilical Catheter Device: Neosense Umbilical Catheter
The Neosense umbilical catheter is used instead of the routinely used umbilical catheter


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Clinical complications with the Neosense catheter. [ Time Frame: During study, up to 8 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.

  2. Any deviations from normal procedures when inserting an umbilical catheter. [ Time Frame: During day 1 ]
    Number of attempts to place the catheter for each patient. Any accessories needed to introduce or handle the Neosense catheter.

  3. Number of monitor lockups or battery depletions [ Time Frame: During study, in average 4-5 days ]
    Timepoint for monitor lockup or battery depletion, in case of occurrence.

  4. Usability and functionality of the Neosense monitor. [ Time Frame: During study, in average 4-5 days ]
    Occurence of anticipated adverse device effects for the monitor.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03967587


Contacts
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Contact: Principal Investigator +46 8 517 700 00 mats.blennow-bohlin@sll.se

Locations
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Sweden
Karolinska University Hospital Recruiting
Huddinge, Sweden
Contact: Mats B Blennow         
Sponsors and Collaborators
Neosense Technologies
Investigators
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Principal Investigator: Mats B Blennow, MD, Prof. Karolinska University Hospital
More Information
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Responsible Party: Neosense Technologies
ClinicalTrials.gov Identifier: NCT03967587    
Other Study ID Numbers: IMPROVE
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Neosense Technologies:
Neonatal
Umbilical Arteries
Umbilical Veins
Oxygen Partial Pressure