NCT04774848 High Frequency Oscillatory Ventilation Versus High Frequency Jet Ventilation for Congenital Diaphragmatic Hernia
| NCT ID | NCT04774848 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Utah |
| Condition | Congenital Diaphragmatic Hernia |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2020-12-30 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2020-12-30 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Admitted to either the University of Utah and/or Primary Children's Hospital NICU within 24 hours of birth 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. Severe anomaly 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
Contact & Investigator
Michelle Yang, MD
PRINCIPAL INVESTIGATOR
University of Utah
Frequently Asked Questions
Who can join the NCT04774848 clinical trial?
This trial is open to participants of all sexes, up to 24 Hours, studying Congenital Diaphragmatic Hernia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04774848 currently recruiting?
Yes, NCT04774848 is actively recruiting participants. Contact the research team at michelle.yang@hsc.utah.edu for enrollment information.
Where is the NCT04774848 trial being conducted?
This trial is being conducted at Salt Lake City, United States, Salt Lake City, United States.
Who is sponsoring the NCT04774848 clinical trial?
NCT04774848 is sponsored by University of Utah. The principal investigator is Michelle Yang, MD at University of Utah. The trial plans to enroll 50 participants.