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

Lung Diseases Clinical Trial

— IMPROVE-2  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05433779
• Other study ID #: IMPROVE-2
• Status: Terminated
• Phase: N/A
• Start date: December 15, 2022
• Est. completion date: June 16, 2023

Study information

• Verified date: September 2023
• Source: Neosense Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: June 16, 2023
• Est. primary completion date: June 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Catheter
• Lung Diseases
• Newborn, Infant, Disease

Intervention

Device:
• Neosense Umbilical Catheter
The Neosense umbilical catheter is used instead of the routinely used umbilical catheter

Locations

Country	Name	City	State
Sweden	Danderyd Hospital	Danderyd
Sweden	Karolinska University Hospital	Huddinge
Sweden	Karolinska University Hospital	Solna
Sweden	Södersjukhuset	Stockholm
Sweden	Uppsala University Children's Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Neosense Technologies

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Any deviations from normal procedures when inserting an umbilical catheter	Number of attempts to place the catheter for each patient.	During day 1
Secondary	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
Secondary	Adverse device effects of the Neosense monitor.	Occurence of anticipated adverse device effects for the monitor.	During study, in average 4-5 days
Secondary	Any deviations from normal procedures when inserting an umbilical catheter.	Any accessories needed to introduce the Neosense catheter.	During day 1
Secondary	Any deviations from normal procedures when inserting an umbilical catheter.	Any accessories needed to handle the Neosense catheter during insertion.	During day 1