Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT06171867
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2023-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PNEUMACRIT Device for Neonatal Cardio Respiratory Monitoring
Sponsor:
University of Oulu
Organization:
Study Overview
Official Title:
Preterm Neonate/ Neonatal Embedded Universal Microelectronic Wearable Acquisition for Cardio Respiratory Intensive Therapy. Clinical Assessment of Device Usability and Reliability
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PNEUMACRIT
Brief Summary:
The usability of a new PNEUMACRIT system is studied in clinical environment in this feasibility study.
Detailed Description:
Electrical impedance tomography is a noninvasive monitoring tool for neonatal lung aeration and breathing. This feasibility study will assess the usability of a new PNEUMACRIT electrode belt in clinical environment.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: