Ignite Creation Date:
2025-12-17 @ 1:44 PM
Ignite Modification Date:
2025-12-23 @ 4:54 PM
Study NCT ID:
NCT01873261
Status:
UNKNOWN
Last Update Posted:
2013-06-10
First Post:
2013-02-19
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NIV NAVA Versus NIV-PS in Pediatric Patients - Pilot Study
Sponsor:
Hospital Universitario La Paz
Organization:
Study Overview
Official Title:
Neurally Adjusted Ventilatory Assist (NAVA) Versus Pressure Support in Pediatric Acute Respiratory Failure - Pilot Study
Status:
UNKNOWN
Status Verified Date:
2013-06
Last Known Status:
RECRUITING
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:
NINAVAPed
Brief Summary:
This pilot study will be an observational no randomize study in which the NiNAVAped protocol will be applied solely to the NIV NAVA arm.
Detailed Description:
This pilot study will be an observational no randomize study in which the NiNAVAped protocol will be applied solely to the NIV NAVA arm.
Every PICU will have to include 3 patients in the Pilot study before starting the clinical trial, which means that the pilot study will involve a maximum of 60 patients.
Should the Pilot study reveal deficiencies in the NiNAVAped design, the protocol would be improved accordingly.
There will be a specific consent document during the Pilot study. The Pilot study will be published in a scientific journal.
Every PICU will have to include 3 patients in the Pilot study before starting the clinical trial, which means that the pilot study will involve a maximum of 60 patients.
Should the Pilot study reveal deficiencies in the NiNAVAped design, the protocol would be improved accordingly.
There will be a specific consent document during the Pilot study. The Pilot study will be published in a scientific journal.
Study Oversight
Has Oversight DMC:
False
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?: