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

Last updated: April 1, 2025
Sponsor: University of Utah
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hernia

Pentalogy Of Cantrell

Treatment

High Frequency Jet Ventilator

High Frequency Oscillatory Ventilator

Clinical Study ID

NCT04774848
133683
  • Ages < 24
  • All Genders

Study 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

Inclusion Criteria:

  1. Admitted to either the University of Utah and/or Primary Children's Hospital NICUwithin 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

Exclusion Criteria:

  1. Severe anomaly

  2. Chromosomal abnormalities

  3. Major congenital anomalies, including cardiac, central nervous system andsyndromes

  4. Post-natal diagnosis > 24 hours of life

  5. Unable to obtain consent for participation

  6. Unable to randomize within 24 hours of life

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: High Frequency Jet Ventilator
Phase:
Study Start date:
December 30, 2020
Estimated Completion Date:
August 28, 2025

Connect with a study center

  • Primary Children's Hospital

    Salt Lake City, Utah 84113
    United States

    Active - Recruiting

  • University Hospital

    Salt Lake City, Utah 84132
    United States

    Active - Recruiting

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