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

Sponsor
Neosense Technologies (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05433779
Collaborator
(none)
50
Enrollment
1
Arm
7
Anticipated Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Device: Neosense Umbilical Catheter
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 -2
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. Measurement performance (continuously) of an intravascular oxygen sensor in the Neosense system [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 [During day 1]

    Number of attempts to place the catheter for each patient.

  3. Number of monitor lock up or battery depletions [During study, in average 4-5 days]

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

  4. Adverse device effects of the Neosense monitor. [During study, in average 4-5 days]

    Occurence of anticipated adverse device effects for the monitor.

  5. Any deviations from normal procedures when inserting an umbilical catheter. [During day 1]

    Any accessories needed to introduce the Neosense catheter.

  6. Any deviations from normal procedures when inserting an umbilical catheter. [During day 1]

    Any accessories needed to handle the Neosense catheter during insertion.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Neosense Technologies

Investigators

  • Principal Investigator: Richard Sindelar, MD PhD, Uppsala University Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Neosense Technologies
ClinicalTrials.gov Identifier:
NCT05433779
Other Study ID Numbers:
  • IMPROVE-2
First Posted:
Jun 27, 2022
Last Update Posted:
Jun 27, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Oxygen Partial Pressure
Additional relevant MeSH terms:
Lung Diseases

Study Results

No Results Posted as of Jun 27, 2022