Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal IntensiVE Care Patients -3

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

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Key information

Conditions

Catheters, Indwelling Compromised Health Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Preterm Birth Urogenital Diseases

Age range

0 year–1 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Östra/Sahlgrenska University Hospital, Gothenburg, Halland County, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neosense umbilical catheter

Device

The Neosense umbilical catheter is used instead of a standard umbilical catheter

Primary outcomes

Clinical complications with the Neosense catheter.

Time frame: During study, up to 5 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.

Secondary outcomes

Measurement performance (continuously) of an intravascular oxygen sensor in the Neosense system

Time frame: Measurement comparisons done at every blood gas sample, i.e. every 4th - 6th hour during the study (up to 5 days)

The oxygen tension measured by the Neosense system, compared to the oxygen tension measured by a blood gas analyser.

Sponsors and collaborators

Lead sponsor

Neosense Technologies

Industry

Registry information

Acronym: IMPROVE

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Sep 27, 2024
Registry last updated: Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed