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ENROLLING BY INVITATION
NCT06616012
NA

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

Sponsor: Neosense Technologies

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

0 Years - 1 Day

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2023-09-14

Completion Date

2025-03-30

Last Updated

2024-09-27

Healthy Volunteers

No

Interventions

DEVICE

Neosense umbilical catheter

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

Locations (6)

Östra/Sahlgrenska University Hospital

Gothenburg, Halland County, Sweden

Skåne University Hospital

Lund/Malmö, Skåne County, Sweden

Karolinska University Hospital

Stockholm, Stockholm County, Sweden

Södersjukhuset

Stockholm, Stockholm County, Sweden

Uppsala University Children's Hospital

Uppsala, Uppland, Sweden

Västmanalands Hospital

Västerås, Västmanland County, Sweden