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NCT05433779: IMPROVE-2

Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal intensiVE Care Patients -2

Terminated NA Last updated 21 September 2023
What this trial tests

NA trial testing Neosense Umbilical Catheter in Catheter in 8 participants. Terminated before completion.

Timeline
15 December 2022
Primary endpoint
16 June 2023
16 June 2023

Quick facts

Lead sponsorNeosense Technologies
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment8
Start date15 December 2022
Primary completion16 June 2023
Estimated completion16 June 2023
Sites5 locations across Sweden

Drugs / interventions tested

Conditions studied

Sponsor

Neosense Technologies

Who can join

Eligibility, any sex, with Catheter or Newborn, Infant, Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05433779.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing