High Frequency Oscillatory Ventilation Versus High Frequency Jet Ventilation as Initial Mode of Ventilation for Congenital Diaphragmatic Hernia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Congenital Diaphragmatic Hernia
- Sponsor
- University of Utah
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Oxygenation Index (OI) at 24 hours of age
- Status
- Recruiting
- Last Updated
- last year
Overview
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 Children's 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.
Investigators
Michelle Yang
Principal Investigator
University of Utah
Eligibility Criteria
Inclusion Criteria
- •Admitted to either the University of Utah and/or Primary Children's Hospital NICU within 24 hours of birth
- •Requiring mechanical ventilation
- •Umbilical arterial line or peripheral arterial line in place
- •Obtained signed consent
- •Infant is ≤ 24 hours of age
Exclusion Criteria
- •Severe anomaly
- •Chromosomal abnormalities
- •Major congenital anomalies, including cardiac, central nervous system and syndromes
- •Post-natal diagnosis \> 24 hours of life
- •Unable to obtain consent for participation
- •Unable to randomize within 24 hours of life
Outcomes
Primary Outcomes
Oxygenation Index (OI) at 24 hours of age
Time Frame: 24 hours of age
The OI will be measured at 24 hours of age using a standard of care arterial blood gas and oxygen settings. These measurements will then be compared between the stratified groups
Secondary Outcomes
- PF ratio (PaO2/FiO2) measurements(up to one week)
- PF-PCO2 (PaO2/FiO2-PaCO2) measurements(up to one week)
- Number of babies who received inhaled nitric oxide (iNO)(up to one week)
- PaCO2 measurements(up to one week)