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

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT04774848
Status
Recruiting
Apply to this trial

Conditions

  • Congenital Diaphragmatic Hernia

Eligibility Criteria

Sex
ALL
Age
N/A - 24 Hours
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Dec 30, 2020
Status verified
Jan 2025
Primary completion
Jun 30, 2025
Completion
Aug 28, 2025

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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.
  • Active Comparator: 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.
  • Active Comparator: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Oxygenation Index (OI) at 24 hours of age [ Time Frame: 24 hours of age ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Primary Children's HospitalSalt Lake CityUtah84113
Michelle Yang, MD
[email protected]
801-581-7052
Kimberlee Weaver-Lewis, RN
[email protected]
801-507-7675
Michelle Yang, MD (PRINCIPAL_INVESTIGATOR)
University HospitalSalt Lake CityUtah84132
Michelle Yang, MD
[email protected]
801-581-7052
Carrie Rau, RN
[email protected]
801-213-3360
Michelle Yang, MD (PRINCIPAL_INVESTIGATOR)

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Primary Children's Hospital· Salt Lake City, UTUniversity Hospital· Salt Lake City, UT

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