Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04774848
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2021-02-24
Brief Title:
High Frequency Oscillatory Ventilation Versus High Frequency Jet Ventilation for Congenital Diaphragmatic Hernia
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
High Frequency Oscillatory Ventilation Versus High Frequency Jet Ventilation as Initial Mode of Ventilation for Congenital Diaphragmatic Hernia
Status:
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:
The purpose of this study is to conduct a prospective study of all congenital diaphragmatic hernia CDH neonates managed at the University of Utah newborn intensive care unit NICU and Primary Childrens Hospital NICU that required mechanical ventilation at birth As both high frequency jet ventilation HFJV and high frequency oscillatory ventilation HFOV are standard approaches to ventilatory support of all neonates including CDH CDH infants will be randomized at the time of birth or admission to either HFJV or HFOV as initial ventilator mode stratified by position of the liver in the abdomen or thorax if known by 24 hours of age Measures of oxygenation ventilation and hemodynamics of the CDH cohort managed on HFOV compared to those on HFJV
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?:
False
Is an FDA AA801 Violation?:
None