NCT Number: NCT04774848
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.
Interested in participating?
Request InfoUp to 24 hour
All sexes
Interventional
Not applicable
Primary Children's Hospital, Salt Lake City, Utah, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
HFJV provides short bursts of gas into the respiratory circuit at a rate of 240 to 600/min (4 to 11 Hz) and expiration is passive. It is used in conjunction with a conventional ventilator which provides positive end expiratory pressure (PEEP) and can also provide occasional sigh breaths.
HFOV uses a piston diaphragm to generate alternating positive and negative pressure changes to give breaths of 300 to 900/min (5-15 Hz) given over a set mean airway pressure. Both inhalation and exhalation are active.
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
Time frame: up to one week
These measurements will be determined at multiple time points for the first week of life. These measurements will be compared between groups.
Time frame: up to one week
These measurements will be determined at multiple time points for the first week of life. These measurements will be compared between groups.
Time frame: up to one week
These measurements will be determined at multiple time points for the first week of life. These measurements will be compared between groups.
Time frame: up to one week
the number of babies who received treatment of iNO will be compared amongst the different groups
Time frame: up to one year
the number of babies who survive and are discharged will be compared amongst the groups
Time frame: up to one year
the number of babies who required ECMO will be compared amongst the groups
Time frame: up to one year
the number of days each baby required intubation and mechanical ventilation by any type will be compared amongst the groups
Contact information is provided by the study sponsor or research team.
Carrie Rau
CONTACT
Michelle Yang, MD
CONTACT
University of Utah
Other
High Frequency Oscillatory Ventilation Versus High Frequency Jet Ventilation as Initial Mode of Ventilation for Congenital Diaphragmatic Hernia
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