High Frequency Oscillatory Ventilation Versus High Frequency Jet Ventilation for Congenital Diaphragmatic Hernia

Study 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.

Official Title
-----------------
High Frequency Oscillatory Ventilation Versus High Frequency Jet Ventilation as Initial Mode of Ventilation for Congenital Diaphragmatic Hernia

Conditions
-----------------
Congenital Diaphragmatic Hernia

Intervention / Treatment
-----------------
* Device: High Frequency Jet Ventilator
* Device: High Frequency Oscillatory Ventilator


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Maximum Age: 24 Hours

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Infants stratified by presence of intrathoracic liver (yes/no) and are randomized to either high frequency jet ventilator or high frequency oscillating ventilator in a sequential 1:1 manner
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Frequency Jet Ventilation (HFJV) with intrathoracic liver<br>Babies known to have the presence of the liver in the intrathoracic space will be placed on the HFJV at delivery or as soon as possible after consent. During analysis, these babies will be compared to babies with intrathoracic liver and randomized to high frequency oscillating ventilator. | Device: High Frequency Jet Ventilator<br>* 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.<br>|
| Active Comparator: High Frequency Jet Ventilation (HFJV) without intrathoracic liver<br>Babies who do not have any liver in the intrathoracic space will be placed on the HFJV at delivery or as soon as possible after consent. During analysis, these babies will be compared to babies without intrathoracic liver and randomized to high frequency oscillating ventilator. | Device: High Frequency Jet Ventilator<br>* 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.<br>|
| Active Comparator: High Frequency Oscillatory Ventilation (HFOV) with intrathoracic liver<br>Babies known to have the presence of the liver in the intrathoracic space will be placed on the HFOV at delivery or as soon as possible after consent. During analysis, these babies will be compared to babies with intrathoracic liver and randomized to HFJV. | Device: High Frequency Oscillatory Ventilator<br>* 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.<br>|
| Active Comparator: High Frequency Oscillatory Ventilation (HFOV) without intrathoracic liver<br>Babies who do not have any liver in the intrathoracic space will be placed on the HFOV at delivery or as soon as possible after consent. During analysis, these babies will be compared to babies without intrathoracic liver and randomized to HFJV. | Device: High Frequency Oscillatory Ventilator<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygenation 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 | 24 hours of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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 | up to one week |