Congenital Diaphragmatic HerniaNCT04774848
High Frequency Oscillatory Ventilation Versus High Frequency Jet Ventilation for Congenital Diaphragmatic Hernia
A study testing High Frequency Jet Ventilator and High Frequency Oscillatory Ventilator in people with Congenital Diaphragmatic Hernia, run by University of Utah at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 24 hours
- Conditions the study is for
- Congenital Diaphragmatic Hernia
- What is being tested?
- High Frequency Jet Ventilator and High Frequency Oscillatory Ventilator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Dec 2020to 28 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Primary Children's Hospital
Salt Lake City, Utah, 84113
Michelle Yang, MD, 801-581-7052, michelle.yang@hsc.utah.edu
Kimberlee Weaver-Lewis, RN, 801-507-7675, kimberlee.weaverlewis@imail.org
- Recruiting
University Hospital
Salt Lake City, Utah, 84132
Michelle Yang, MD, 801-581-7052, michell.yang@hsc.utah.edu
Carrie Rau, RN, 801-213-3360, carrie.rau@hsc.utah.edu
About this study
Official title: High Frequency Oscillatory Ventilation Versus High Frequency Jet Ventilation as Initial Mode of Ventilation for Congenital Diaphragmatic Hernia
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.
- Conditions
- Congenital Diaphragmatic Hernia
- Being tested
- High Frequency Jet Ventilator, High Frequency Oscillatory Ventilator
- Medical subject headings
- Hernias, Diaphragmatic, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Frequency Jet VentilatorDevice
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.
High Frequency Oscillatory VentilatorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: High Frequency Jet 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. Receives: Device: High Frequency Jet 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. Receives: Device: High Frequency Oscillatory Ventilator |
| 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. Receives: Device: High Frequency Oscillatory Ventilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours of age
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: up to one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start30 Dec 2020
- Primary completion30 Jun 2025 (estimated)
- Study completion28 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Diaphragmatic HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Yang, University of Utah
- Investigators
- Michelle Yang, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774848
- Sponsor's protocol ID
- 133683
- Status last verified
- Jan 2025
- First submitted
- 24 Feb 2021
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Frequency Oscillatory Ventilation Versus High Frequency Jet Ventilation as Initial Mode of Ventilation for Congenital Diaphragmatic Hernia
- ClinicalTrials.gov ID
- NCT04774848
- Acronym / sponsor ID
- 133683
- Conditions
- Congenital Diaphragmatic Hernia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 28 Aug 2025 (estimated)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| High Frequency Jet Ventilation (HFJV) with intrathoracic liver | Active comparator | Device: High Frequency Jet VentilatorBabies 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 | Device: High Frequency Jet VentilatorBabies 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 | Device: High Frequency Oscillatory VentilatorBabies 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 | Device: High Frequency Oscillatory VentilatorBabies 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. |
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Severe anomaly
- Post-natal diagnosis > 24 hours of life
- Unable to obtain consent for participation
- Unable to randomize within 24 hours of life
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Frequency Jet VentilatorHFJV 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. | Device | High Frequency Jet Ventilation (HFJV) with intrathoracic liver, High Frequency Jet Ventilation (HFJV) without intrathoracic liver |
| High Frequency Oscillatory VentilatorHFOV 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. | Device | High Frequency Oscillatory Ventilation (HFOV) with intrathoracic liver, High Frequency Oscillatory Ventilation (HFOV) without intrathoracic liver |
Primary outcome
Oxygenation Index (OI) at 24 hours of age
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
4 secondary outcomes
PF ratio (PaO2/FiO2) measurements
Time frame: up to one week
PF-PCO2 (PaO2/FiO2-PaCO2) measurements
Time frame: up to one week
PaCO2 measurements
Time frame: up to one week
Number of babies who received inhaled nitric oxide (iNO)
Time frame: up to one week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle Yang, MD principal investigator
University of Utah
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Frequency Jet Ventilator and High Frequency Oscillatory Ventilator in people with Congenital Diaphragmatic Hernia, run by University of Utah at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Yang, MD (801-581-7052, michelle.yang@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenation Index (OI) at 24 hours of age (time frame: 24 hours of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025; AzTrials last refreshed its copy on 30 Oct 2026.