Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06436222
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-20
Brief Title:
Effectiveness of HVNI in Preterm Infants With Moderate Respiratory Distress
Sponsor:
Indonesia University
Organization:
Indonesia University
Study Overview
Official Title:
Effectiveness of High Velocity Nasal Insufflation HVNI in Infants 32 Weeks Gestational AgeGA or Birth Weight 1500 Grams With Moderate Respiratory Distress in DrCipto Mangunkusumo Hospital
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:
None
Brief Summary:
Neonatal respiratory distress is a common problem in preterm infants The application of CPAP is widely used in neonatal units as a primary mode of respiratory support for respiratory distress However discomfort nasal injuries and fixation difficulties have been reported as obstacles when applying CPAP High velocity nasal insufflation HVNI may serve as an alternative to CPAP Trials are needed to evaluate the effectiveness of HVNI in reducing the incidence of respiratory distress The aim of this study is to compare the clinical effectiveness and safety of HVNI as an alternative therapy to CPAP in premature infants with moderate respiratory distress This study is a prospective non-inferiority randomized unblinded controlled trial to compare the efficacy of HVNI and CPAP The subjects were randomly allocated to receive either HVNI or CPAP according to the study protocol They were randomly assigned using blocks of four The completion of HVNI therapy was determined by therapeutic failure within 72 hours following enrollment indicated by the need for intubation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None