NCT06616012

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Neosense Technologies · Industry
• Sex: All
• Age: 0 Years – 1 Day
• Healthy volunteers: Not accepted

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

Conditions

• Catheters, Indwelling
• Preterm Birth
• Compromised Health

Interventions

Type	Name	Description
DEVICE	Neosense umbilical catheter	The Neosense umbilical catheter is used instead of a standard umbilical catheter

Timeline

• Start date: 2023-09-14
• Primary completion: 2025-03-30
• Completion: 2025-03-30
• First posted: 2024-09-27
• Last updated: 2024-09-27

Locations

6 sites across 1 country: Sweden