High Frequency Oscillatory Ventilation Versus High Frequency Jet Ventilation for Congenital Diaphragmatic Hernia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High Frequency Jet Ventilator, High Frequency Oscillatory Ventilator.
- Who it may be relevant to
- Registry conditions: Congenital Diaphragmatic Hernia. Basic parameters: up to 24 Hours · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
High Frequency Oscillatory Ventilation Versus High Frequency Jet Ventilation as Initial Mode of Ventilation for Congenital Diaphragmatic Hernia
Overview
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.
Interventions
- Device 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. - Device 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.
Primary outcome measures
- Oxygenation Index (OI) at 24 hours of age [Time frame: 24 hours of age]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Primary Children's Hospital — Salt Lake City
- University Hospital — Salt Lake City
Identifiers
NCT: NCT04774848 · 133683