High Frequency Oscillatory Ventilation Versus High Frequency Jet Ventilation for Congenital Diaphragmatic Hernia
1 other identifier
interventional
50
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2020
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 30, 2020
CompletedFirst Submitted
Initial submission to the registry
February 24, 2021
CompletedFirst Posted
Study publicly available on registry
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2025
CompletedApril 4, 2025
January 1, 2025
4.5 years
February 24, 2021
April 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
PF ratio (PaO2/FiO2) measurements
up to one week
PF-PCO2 (PaO2/FiO2-PaCO2) measurements
up to one week
PaCO2 measurements
up to one week
Number of babies who received inhaled nitric oxide (iNO)
up to one week
Other Outcomes (3)
Number of babies who survive to discharge
up to one year
Number of babies who required extracorporeal membrane oxygenation (ECMO)
up to one year
Number of days on mechanical ventilation
up to one year
Study Arms (4)
High Frequency Jet Ventilation (HFJV) with intrathoracic liver
ACTIVE COMPARATORBabies 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 COMPARATORBabies 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 COMPARATORBabies 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 COMPARATORBabies 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Primary Children's Hospital
Salt Lake City, Utah, 84113, United States
University Hospital
Salt Lake City, Utah, 84132, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle Yang, MD
University of Utah
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 24, 2021
First Posted
March 1, 2021
Study Start
December 30, 2020
Primary Completion
June 30, 2025
Study Completion
August 28, 2025
Last Updated
April 4, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share