Actively Recruiting

Phase Not Applicable
Age: 0 - 24Hours
All Genders
NCT04774848

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

Led by University of Utah · Updated on 2025-04-04

50

Participants Needed

2

Research Sites

243 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 0 - 24Hours
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Admitted to either the University of Utah and/or Primary Children's Hospital NICU within 24 hours of birth
  • Requires mechanical ventilation
  • Has an umbilical arterial line or peripheral arterial line in place
  • Signed consent has been obtained
  • Infant is less than or equal to 24 hours of age
Not Eligible

You will not qualify if you...

  • Presence of severe anomalies such as chromosomal abnormalities or major congenital anomalies including cardiac, central nervous system, and syndromes
  • Diagnosis made after 24 hours of life
  • Unable to obtain consent for participation
  • Unable to be randomized within 24 hours of life

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Primary Children's Hospital

Salt Lake City, Utah, United States, 84113

Actively Recruiting

2

University Hospital

Salt Lake City, Utah, United States, 84132

Actively Recruiting

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Research Team

M

Michelle Yang, MD

CONTACT

C

Carrie Rau

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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