Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616012
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal IntensiVE Care Patients -3
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal IntensiVE Care Patients -3
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPROVE
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 monitormeasuring 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None