High Frequency Oscillatory Ventilation Versus High Frequency Jet Ventilation for Congenita
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 hig
| Condition(s) | Congenital Diaphragmatic Hernia |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 24 Hours |
| Sex | All |
| Lead sponsor | University of Utah |
| Locations | Salt Lake City, Utah, United States; Salt Lake City, Utah, United States |
| Start date | 2020-12-30 |
| NCT ID | NCT04774848 |
| Official listing | https://clinicaltrials.gov/study/NCT04774848 |