Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05960929
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-02
First Post:
2023-07-06
Brief Title:
InfasurfAero Versus Sham Treatment in Preterm Newborns With RDS
Sponsor:
ONY
Organization:
ONY
Study Overview
Official Title:
InfasurfAero Versus Sham Treatment in Preterm Newborns With RDS A Single-dose Double-blind Random Allocation Sham-control Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
Aero-05
Brief Summary:
The purpose of this clinical study is to determine the effectiveness and safety of Infasurf administered through the InfasurfAero a novel oral airway delivery device specifically designed to give Infasurf in a less complicated way and without the need for a breathing tube or interrupting nasal respiratory support
Detailed Description:
This single-dose double-blind random allocation sham-control clinical trial will recruit spontaneously breathing newborns with RDS stable on non-invasive nasal respiratory support Enrolled clinical study subjects will be randomly allocated to receive respiratory air with Infasurf Intervention Arm or respiratory air alone Sham Control Arm through the InfasurfAero
The objectives of this clinical study are to i assess the effectiveness of a single dose of Infasurf administered through the InfasurfAero in preventing CPAP failure and ii assess the safety of Infasurf administered through the InfasurfAero
Subjects will be enrolled at one of 10 sites 7 sites are currently recruited
The objectives of this clinical study are to i assess the effectiveness of a single dose of Infasurf administered through the InfasurfAero in preventing CPAP failure and ii assess the safety of Infasurf administered through the InfasurfAero
Subjects will be enrolled at one of 10 sites 7 sites are currently recruited
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None