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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
Primary Children's Hospital
Salt Lake City, Utah, United States
RECRUITINGUniversity Hospital
Salt Lake City, Utah, United States
RECRUITINGOxygenation Index (OI) at 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: 24 hours of age
PF ratio (PaO2/FiO2) measurements
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
PF-PCO2 (PaO2/FiO2-PaCO2) measurements
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
PaCO2 measurements
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
Number of babies who received inhaled nitric oxide (iNO)
the number of babies who received treatment of iNO will be compared amongst the different groups
Time frame: up to one week
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.