Clinical trial NCT05433779: Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal intensiVE Care Patients -2
Official title: Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal intensiVE Care Patients -2
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Catheter
Newborn, Infant, Disease
Lung Diseases
Keywords: Neonatal
Umbilical Arteries
Oxygen Partial Pressure
Lead sponsor: Neosense Technologies
Sponsor class: INDUSTRY
First posted: 2022-06-27
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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


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

Primary outcomes:
measure: Measurement performance (continuously) of an intravascular oxygen sensor in the Neosense system
timeFrame: Measurement comparisons done at every blood gas sample, i.e. every 4th - 6th hour during the study (up to 8 days)
Secondary outcomes:
measure: Clinical complications with the Neosense catheter.
timeFrame: Time Frame: During study, up to 8 days
measure: Any deviations from normal procedures when inserting an umbilical catheter
timeFrame: During day 1
measure: Number of monitor lock up or battery depletions
timeFrame: During study, in average 4-5 days
measure: Adverse device effects of the Neosense monitor.
timeFrame: During study, in average 4-5 days
measure: Any deviations from normal procedures when inserting an umbilical catheter.
timeFrame: During day 1
measure: Any deviations from normal procedures when inserting an umbilical catheter.
timeFrame: During day 1
Other outcomes:
Locations:
city: Danderyd
country: Sweden
facility: Danderyd Hospital
city: Huddinge
country: Sweden
facility: Karolinska University Hospital
city: Solna
country: Sweden
facility: Karolinska University Hospital
city: Stockholm
country: Sweden
facility: Södersjukhuset
city: Uppsala
country: Sweden
facility: Uppsala University Children's Hospital
Study officials:
affiliation: Uppsala University Children's Hospital
name: Richard Sindelar, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: