High Frequency Oscillatory Ventilation Versus High Frequency Jet Ventilation for Congenital Diaphragmatic Hernia
NCT ID: NCT04774848
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2020-12-30
2025-08-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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High Frequency Jet Ventilation (HFJV) with intrathoracic liver
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 Ventilator
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 Jet Ventilation (HFJV) without intrathoracic liver
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 Jet Ventilator
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 Ventilation (HFOV) with intrathoracic liver
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 Ventilator
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.
High Frequency Oscillatory Ventilation (HFOV) without intrathoracic liver
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.
High Frequency Oscillatory Ventilator
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.
Interventions
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High Frequency Jet Ventilator
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 Ventilator
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
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Inclusion Criteria
2. Requiring mechanical ventilation
3. Umbilical arterial line or peripheral arterial line in place
4. Obtained signed consent
5. Infant is ≤ 24 hours of age
Exclusion Criteria
1. Chromosomal abnormalities
2. Major congenital anomalies, including cardiac, central nervous system and syndromes
2. Post-natal diagnosis \> 24 hours of life
3. Unable to obtain consent for participation
4. Unable to randomize within 24 hours of life
24 Hours
ALL
No
Sponsors
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University of Utah
OTHER
Responsible Party
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Michelle Yang
Principal Investigator
Principal Investigators
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Michelle Yang, MD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
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Primary Children's Hospital
Salt Lake City, Utah, United States
University Hospital
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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133683
Identifier Type: -
Identifier Source: org_study_id
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