Comparing two types of ventilation for newborns with congenital diaphragmatic hernia
High Frequency Oscillatory Ventilation Versus High Frequency Jet Ventilation as Initial Mode of Ventilation for Congenital Diaphragmatic Hernia
This study is testing whether high frequency jet ventilation or high frequency oscillatory ventilation works better for newborns with congenital diaphragmatic hernia who need help breathing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | N/A to 24 Hours |
| Sex | All |
| Sponsor | University of Utah Academic / other |
| Locations | 2 sites (Salt Lake City, Utah and 1 other locations) |
| Trial ID | NCT04774848 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of high frequency jet ventilation (HFJV) versus high frequency oscillatory ventilation (HFOV) in neonates diagnosed with congenital diaphragmatic hernia (CDH) who require mechanical ventilation. Infants will be randomly assigned to one of the two ventilation methods shortly after birth or admission to the NICU. The study will monitor and compare key measures of oxygenation, ventilation, and hemodynamics between the two groups. The research will take place at the University of Utah and Primary Children's Hospital NICUs.
Who should consider this trial
Good fit: Ideal candidates for this study are neonates diagnosed with congenital diaphragmatic hernia who are admitted to the NICU within 24 hours of birth and require mechanical ventilation.
Not a fit: Patients with severe anomalies or those who cannot be randomized within 24 hours of life may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve ventilation strategies for newborns with congenital diaphragmatic hernia, potentially leading to better clinical outcomes.
How similar studies have performed: While both HFJV and HFOV are standard practices, this study's direct comparison in the context of CDH is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Salt Lake City, Utah and 1 other locations
- Primary Children's Hospital — Salt Lake City, Utah, United States (Recruiting)
- University Hospital — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Michelle Yang, MD — University of Utah
- Study coordinator: Michelle Yang, MD
- Email: michelle.yang@hsc.utah.edu
- Phone: 801-581-7052
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.