Comparing two types of ventilation for newborns with congenital diaphragmatic hernia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of high frequency jet ventilation (HFJV) versus high frequency oscillatory ventilation (HFOV) in neonates diagnosed with congenital diaphragmatic hernia (CDH) who require mechanical ventilation. Infants will be randomly assigned to one of the two ventilation methods shortly after birth or admission to the NICU. The study will monitor and compare key measures of oxygenation, ventilation, and hemodynamics between the two groups. The research will take place at the University of Utah and Primary Children's Hospital NICUs.

Why it matters

Who can join: the full rules

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

Where it's running

• Primary Children's Hospital
  Salt Lake City, Utah, United States Recruiting
• University Hospital
  Salt Lake City, Utah, United States Recruiting

Study contacts

• Principal investigator: Michelle Yang, MD — University of Utah
• Study coordinator: Michelle Yang, MD
• Email: michelle.yang@hsc.utah.edu
• Phone: 801-581-7052

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Fetal tracheal occlusion (FETO) for severe congenital diaphragmatic hernia

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• Long-term outcomes after FETO for severe left or right congenital diaphragmatic hernia

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• Fetal treatment for congenital diaphragmatic hernia

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• Fetoscopic balloon (FETO) for severe left and right congenital diaphragmatic hernia — long-term outcomes

  This trial will try placing and later removing a tiny balloon in the fetal windpipe around 27–29 weeks to help babies with severe congenital diaphragmatic hernia and liver herniation survive the newborn period.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.