High Frequency Ventilation for Diaphragmatic Hernia

Recruiting at 1 trial location

Overseen By Carrie Rau

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Chromosomal abnormalities, Major congenital anomalies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to help newborns with congenital diaphragmatic hernia (CDH) breathe immediately after birth. CDH occurs when an opening in the diaphragm allows organs to move into the chest, making breathing difficult. The study compares two types of ventilators—high frequency jet ventilation (HFJV) and high frequency oscillatory ventilation (HFOV)—to determine which is more effective, depending on whether the liver is in the chest. Eligible participants are newborns in the NICU who need a ventilator within 24 hours of birth. As an unphased trial, this study provides a unique opportunity to contribute to vital research that could enhance care for newborns with CDH.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether participants must stop taking their current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What prior data suggests that high frequency ventilation is safe for neonates with diaphragmatic hernia?

Research shows that high-frequency jet ventilation (HFJV) is generally safe for newborns with congenital diaphragmatic hernia (CDH). It benefits babies who don't respond well to regular breathing machines. Studies in both adults and children support its safety and effectiveness.

High-frequency oscillatory ventilation (HFOV) has improved early breathing in infants with severe CDH. It helps them breathe better without affecting their hospital recovery. Some research suggests that HFOV might allow for earlier surgeries, aiding quicker recovery of normal body functions.

Both HFJV and HFOV appear to be safe options for treating newborns with CDH. They manage breathing problems without causing significant harm, according to existing studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of high-frequency ventilation techniques for diaphragmatic hernia because these methods offer unique advantages over traditional mechanical ventilation. Unlike standard treatments, which often involve conventional ventilators that may not provide optimal lung protection, high-frequency jet ventilation (HFJV) and high-frequency oscillatory ventilation (HFOV) deliver rapid, small breaths to minimize lung injury while maintaining effective gas exchange. This is particularly important for newborns with diaphragmatic hernia, as their lungs are often underdeveloped and more susceptible to damage. By providing a gentler form of ventilation, these techniques aim to improve outcomes and reduce complications for these vulnerable patients.

What evidence suggests that this trial's ventilator treatments could be effective for congenital diaphragmatic hernia?

Research has shown that High Frequency Jet Ventilation (HFJV), a treatment in this trial, effectively treats newborns with congenital diaphragmatic hernia (CDH). It serves well as the primary breathing support and aids babies who do not improve with conventional mechanical ventilation (CMV). In this trial, some participants will receive HFJV. For High Frequency Oscillatory Ventilation (HFOV), another treatment option in this trial, results are mixed. Some studies have found no major difference between HFOV and CMV in terms of oxygen duration and survival rates. However, other research found higher death rates in CDH infants using HFOV compared to those on CMV. Overall, HFJV may offer better outcomes for high-risk CDH cases. ^{1 2 3 6 7}

Who Is on the Research Team?

Michelle Yang, MD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

This trial is for newborns with congenital diaphragmatic hernia who need mechanical ventilation and are admitted to specific NICUs within 24 hours of birth. They must have an arterial line in place. Babies with severe or major anomalies, chromosomal abnormalities, or diagnosed after 24 hours aren't eligible.

Inclusion Criteria

Umbilical arterial line or peripheral arterial line in place

You need to use a machine to help you breathe.

Admitted to either the University of Utah and/or Primary Children's Hospital NICU within 24 hours of birth

Exclusion Criteria

You have significant birth defects or conditions affecting the heart, brain, or overall development.

You have a serious abnormality.

Unable to obtain consent for participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Initial Ventilation

Neonates are randomized to either HFJV or HFOV as the initial ventilator mode

24 hours

Continuous monitoring

Monitoring and Treatment

Oxygenation, ventilation, and hemodynamics are measured and compared between groups

1 week

Multiple assessments

Follow-up

Participants are monitored for survival, ECMO requirement, and discharge outcomes

up to 1 year

Periodic assessments

What Are the Treatments Tested in This Trial?

Interventions

• High Frequency Jet Ventilator
• High Frequency Oscillatory Ventilator

Trial Overview

The study compares two types of ventilator support for newborns: High Frequency Jet Ventilation (HFJV) and High Frequency Oscillatory Ventilation (HFOV). Newborns will be randomly assigned to one of these methods right after birth or upon NICU admission.

How Is the Trial Designed?

Group I: High Frequency Oscillatory Ventilation (HFOV) without intrathoracic liver Active Control 1 Intervention

Babies who do not have any liver in the intrathoracic space will be placed on the HFOV at delivery or as soon as possible after consent. During analysis, these babies will be compared to babies without intrathoracic liver and randomized to HFJV.

Group II: High Frequency Oscillatory Ventilation (HFOV) with intrathoracic liver Active Control 1 Intervention

Babies known to have the presence of the liver in the intrathoracic space will be placed on the HFOV at delivery or as soon as possible after consent. During analysis, these babies will be compared to babies with intrathoracic liver and randomized to HFJV.

Group III: High Frequency Jet Ventilation (HFJV) with intrathoracic liver Active Control 1 Intervention

Babies known to have the presence of the liver in the intrathoracic space will be placed on the HFJV at delivery or as soon as possible after consent. During analysis, these babies will be compared to babies with intrathoracic liver and randomized to high frequency oscillating ventilator.

Group IV: High Frequency Jet Ventilation (HFJV) without intrathoracic liver Active Control 1 Intervention

Babies who do not have any liver in the intrathoracic space will be placed on the HFJV at delivery or as soon as possible after consent. During analysis, these babies will be compared to babies without intrathoracic liver and randomized to high frequency oscillating ventilator.

High Frequency Jet Ventilator is already approved in United States, European Union, Canada for the following indications:

Approved in United States as High Frequency Jet Ventilator for:

• Respiratory distress syndrome in neonates
• Congenital diaphragmatic hernia

Approved in European Union as High Frequency Jet Ventilator for:

• Respiratory distress syndrome in neonates
• Congenital diaphragmatic hernia

Approved in Canada as High Frequency Jet Ventilator for:

• Respiratory distress syndrome in neonates
• Congenital diaphragmatic hernia

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

A study of 370 and 371 suspected adverse drug reaction (ADR) reports from 2007 and 2008 revealed that about 32% and 40% of these reports were deemed incomplete, categorized as grade 0 under Mexican Official Norm guidelines, indicating insufficient information for risk assessment.

The pharmaceutical industry was the primary source of these reports, contributing 58% and 63% of the total in each year, highlighting the need for improved reporting practices to enhance drug safety evaluations in Mexico.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of completeness of suspected adverse drug reaction reports submitted to the mexican national pharmacovigilance centre: a cross-sectional period-prevalence study. Sánchez-Sánchez, B., Altagracia-Martínez, M., Kravzov-Jinich, J., et al.[2021]

High frequency jet ventilation (HFJV) can be effectively used as both a primary ventilation strategy and a rescue option for infants with congenital diaphragmatic hernia (CDH), based on a review of 56 patients treated between 2013 and 2021.

Despite HFJV being associated with longer invasive ventilation days and a greater need for supplemental oxygen at discharge, there were no significant differences in survival rates or complications like pneumothorax compared to conventional mechanical ventilation (CMV).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High frequency jet ventilation for congenital diaphragmatic hernia. Al Kharusi, AA., Al Maawali, A., Traynor, M., et al.[2023]

High-frequency jet ventilation (HFJV) is a promising mechanical ventilation technique that has been effective in treating severe neonatal respiratory distress syndrome.

Current research is exploring the potential of HFJV as a treatment option for adult respiratory distress syndrome in older children, indicating its versatility in respiratory support across different age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-frequency jet ventilation for severe respiratory failure. Gordin, P.[2005]

In a study of 27 newborns with congenital diaphragmatic hernia (CDH) who were transitioned from conventional ventilation to high frequency ventilation (HFV), both high frequency jet ventilation (HFJV) and high frequency oscillatory ventilation (HFOV) significantly improved ventilation and reduced carbon dioxide levels (PaCO2).

However, HFOV resulted in a greater increase in mean airway pressure (Pāw) compared to HFJV, suggesting that while both methods are effective, HFOV may provide better airway pressure support in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rescue high frequency ventilation for congenital diaphragmatic hernia. Attar, MA., Dechert, RE., Donn, SM.[2020]

High-frequency jet ventilation (HFJV) is a mechanical respiratory support technique that provides benefits such as reduced risk of barotrauma and less interference with hemodynamic function, making it potentially safer for patients in respiratory failure.

In a clinical experience involving 39 patients, synchronization of HFJV with heart rate led to increased cardiac output and ejection fraction in three patients, suggesting HFJV may be particularly effective for those with major airway disruptions, though further extensive clinical trials are needed to fully understand its advantages and limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-frequency jet ventilation: theoretical considerations and clinical observations. Carlon, GC., Ray, C., Pierri, MK., et al.[2019]

Anaesthesia devices, despite making up only 2.3% of newly marketed medical devices in Canada, accounted for a significant 8.6% of all problem reports and 37.5% of safety alerts, indicating a higher frequency of issues compared to their market share.

The study found that 10.2% of problem reports for anaesthesia devices were classified as the highest safety priority (Class I), which is notably higher than the 4.9% for non-anaesthesia devices, highlighting a greater safety concern associated with anaesthesia equipment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anaesthesia equipment safety in Canada: the role of government regulation. Gilron, I.[2018]

From 2008 to 2016, a pharmacovigilance program reported 2,631 adverse drug reactions in 2,436 patients, highlighting the importance of monitoring drug safety in various healthcare settings, with most reports coming from pharmacists (92.8%).

The majority of adverse reactions were mild to moderate, with skin and gastrointestinal issues being the most common, and 60.9% of patients recovered, indicating that while adverse reactions are significant, many patients can successfully recover with appropriate management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating pharmacovigilance into the routine of pharmacy department: experience of nine years. Pérez-Ricart, A., Gea-Rodríguez, E., Roca-Montañana, A., et al.[2020]

Drug-induced acute kidney injury (DIAKI) accounts for approximately 20% of all acute kidney injury cases in hospitalized patients, with a total estimated number of 521 cases identified in a study of inpatient stays from 2017 to 2018.

The severity of DIAKI is notable, with over half of the cases classified as stage 1 and a mortality rate of 11.1%, highlighting the critical need for better monitoring and reporting of drug-related kidney injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug-Induced Acute Kidney Injury: A Study from the French Medical Administrative and the French National Pharmacovigilance Databases Using Capture-Recapture Method. Rolland, AL., Garnier, AS., Meunier, K., et al.[2021]

Pharmacovigilance (FV) in Italy has shown a low number of adverse drug reaction reports from 1988 to 1994, indicating a need for increased awareness and concern among health officers across different regions.

There is a strong recommendation for enhanced training in FV for medical professionals and the establishment of regional FV services, alongside a national service to ensure effective monitoring and collaboration with European guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pharmacovigilance: education and continuing updating. The role of university institutes]. Mariani, L.[2013]

High-frequency jet ventilation (HFJV) significantly improved the breathing status of two neonates suffering from severe respiratory failure who did not respond to traditional mechanical ventilation.

Despite the initial benefits of HFJV, both patients unfortunately passed away after about a week, with autopsy revealing microscopic lesions that may be linked to the use of HFJV, although these were not the direct cause of death.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term high-frequency jet ventilation in neonates. Neu, J., Hamilton, L., Linehan, J., et al.[2019]

High-frequency jet ventilation (HFJV) is effective in ventilating animals with respiratory failure, but it does not show clear advantages over traditional volume-cycled ventilation (VCV).

HFJV may be particularly beneficial during situations like airway disruption or surgeries involving the trachea or lungs, but further clinical trials and studies are needed to fully understand its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experimental evaluation of high-frequency jet ventilation. Groeger, JS., Carlon, GC., Howland, WS., et al.[2019]

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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 ...

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HFJV appears to be a safe and effective method of providing high frequency rescue therapy for infants with CDH failing conventional mechanical ventilation. Our ...

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HFJV appears effective, both for CMV rescue and as a primary ventilation strategy in high risk CDH. Level of evidence: Level IV. Keywords.

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This systematic review aims to critically appraise the current evidence regarding the safety and efficacy of HFJV in adult and paediatric patients.

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High Frequency Jet Ventilation during Initial Management ...

HFJV appears to be safe and effective providing high frequency rescue therapy for infants with CDH failing conventional mechanical ventilation.