Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458582
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2024-06-09
Brief Title:
High Flow Nasal Cannula Is Appropriate Alternative for Stabilization of Very Premature Infants A Prospective Observational Study
Sponsor:
Charles University Czech Republic
Organization:
Charles University Czech Republic
Study Overview
Official Title:
High Flow Nasal Cannula Is Appropriate Alternative for Stabilization of Very Premature Infants A Prospective Observational Study
Status:
COMPLETED
Status Verified Date:
2024-06
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:
SIMPLSAFE
Brief Summary:
A prospective observational study evaluates the safety and efficacy of using High-Flow Nasal Cannula to stabilize very preterm infants immediately after birth Following placental transfusion high flow nasal cannula at 8 lmin is administered along with intermittent tactile stimulation Criteria for switching to other interventions like continuous positive airway pressure or positive pressure ventilation are set for cases of persistent bradycardia or low SpO2
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?:
None