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

Recruiting now · Not applicable

Conditions studied: Congenital Diaphragmatic Hernia

In brief

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 facts

Study ID

NCT04774848

Run by

University of Utah

People needed

50

Starts

2020-12-30

Expected to finish

2025-08-28

Last updated by the study team

2025-04-04

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Primary Children's Hospital — Salt Lake City, Utah, United States (enrolling)
• University Hospital — Salt Lake City, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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