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

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 Overview

• Status: Terminated
• Conditions: Lung Diseases; Catheter; Newborn, Infant, Disease
• Intervention / Treatment: Device: Neosense Umbilical Catheter

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Danderyd, Sweden
    • Danderyd Hospital
  • Huddinge, Sweden
    • Karolinska University Hospital
  • Solna, Sweden
    • Karolinska University Hospital
  • Stockholm, Sweden
    • Södersjukhuset
  • Uppsala, Sweden
    • Uppsala University Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neosense Umbilical Catheter	Device: Neosense Umbilical Catheter; The Neosense umbilical catheter is used instead of the routinely used umbilical catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Measurement comparisons done at every blood gas sample, i.e. every 4th - 6th hour during the study (up to 8 days)

Secondary Outcome Measures

Outcome Measure	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.	Time Frame: During study, up to 8 days
Any deviations from normal procedures when inserting an umbilical catheter	Number of attempts to place the catheter for each patient.	During day 1
Number of monitor lock up or battery depletions	Timepoint for monitor lock up or battery depletion, in case of occurrence	During study, in average 4-5 days
Adverse device effects of the Neosense monitor.	Occurence of anticipated adverse device effects for the monitor.	During study, in average 4-5 days
Any deviations from normal procedures when inserting an umbilical catheter.	Any accessories needed to introduce the Neosense catheter.	During day 1
Any deviations from normal procedures when inserting an umbilical catheter.	Any accessories needed to handle the Neosense catheter during insertion.	During day 1

Collaborators and Investigators

• Sponsor: Neosense Technologies
• Investigators: Principal Investigator: Richard Sindelar, MD PhD, Uppsala University Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Actual): June 16, 2023
• Study Completion (Actual): June 16, 2023

Study Registration Dates

• First Submitted: June 14, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Neonatal; Umbilical Arteries; Oxygen Partial Pressure
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: IMPROVE-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No