RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

High Frequency Oscillatory Ventilation Versus High Frequency Jet Ventilation as Initial Mode of Ventilation for Congenital Diaphragmatic Hernia

Quick Facts

Study Start:2020-12-30
Study Completion:2025-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04774848

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 24 Hours
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Admitted to either the University of Utah and/or Primary Children's Hospital NICU within 24 hours of birth
  2. 2. Requiring mechanical ventilation
  3. 3. Umbilical arterial line or peripheral arterial line in place
  4. 4. Obtained signed consent
  5. 5. Infant is ≤ 24 hours of age
  1. 1. Severe anomaly
  2. 1. Chromosomal abnormalities
  3. 2. Major congenital anomalies, including cardiac, central nervous system and syndromes
  4. 2. Post-natal diagnosis \> 24 hours of life
  5. 3. Unable to obtain consent for participation
  6. 4. Unable to randomize within 24 hours of life

Contacts and Locations

Study Contact

Michelle Yang, MD
CONTACT
801-581-7052
michelle.yang@hsc.utah.edu
Carrie Rau
CONTACT
801-213-3360
carrie.rau@hsc.utah.edu

Principal Investigator

Michelle Yang, MD
PRINCIPAL_INVESTIGATOR
University of Utah

Study Locations (Sites)

Primary Children's Hospital
Salt Lake City, Utah, 84113
United States
University Hospital
Salt Lake City, Utah, 84132
United States

Collaborators and Investigators

Sponsor: University of Utah

  • Michelle Yang, MD, PRINCIPAL_INVESTIGATOR, University of Utah

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-30
Study Completion Date2025-02-28

Study Record Updates

Study Start Date2020-12-30
Study Completion Date2025-02-28

Terms related to this study

Additional Relevant MeSH Terms

  • Congenital Diaphragmatic Hernia