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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Frequency Jet Ventilation (HFJV) with intrathoracic liver | Active Comparator | 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. |
|
| High Frequency Jet Ventilation (HFJV) without intrathoracic liver | Active Comparator | 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. |
|
| High Frequency Oscillatory Ventilation (HFOV) with intrathoracic liver | Active Comparator | 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. |
|
| High Frequency Oscillatory Ventilation (HFOV) without intrathoracic liver | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Frequency Jet Ventilator | Device | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of babies who survive to discharge | the number of babies who survive and are discharged will be compared amongst the groups | up to one year |
| Number of babies who required extracorporeal membrane oxygenation (ECMO) |
Inclusion Criteria:
Exclusion Criteria:
Severe anomaly
Post-natal diagnosis > 24 hours of life
Unable to obtain consent for participation
Unable to randomize within 24 hours of life
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michelle Yang, MD | Contact | 801-581-7052 | michelle.yang@hsc.utah.edu | |
| Carrie Rau | Contact | 801-213-3360 | carrie.rau@hsc.utah.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michelle Yang, MD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Primary Children's Hospital | Recruiting | Salt Lake City | Utah | 84113 | United States |
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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
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| High Frequency Oscillatory Ventilator | Device | 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. |
|
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 |
the number of babies who required ECMO will be compared amongst the groups
| up to one year |
| Number of days on mechanical ventilation | the number of days each baby required intubation and mechanical ventilation by any type will be compared amongst the groups | up to one year |
| University Hospital | Recruiting | Salt Lake City | Utah | 84132 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 2, 2026 | Jun 26, 2026 | 5 |
| ID | Term |
|---|---|
| D065630 | Hernias, Diaphragmatic, Congenital |
| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006548 | Hernia, Diaphragmatic |
| D000082122 | Internal Hernia |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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