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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that High Frequency Ventilation for Diaphragmatic Hernia is an effective treatment?

The available research shows that High Frequency Ventilation (HFV), including High Frequency Jet Ventilation (HFJV) and High Frequency Oscillatory Ventilation (HFOV), has been used successfully to help newborns with diaphragmatic hernia when regular breathing machines didn't work. In one study, HFV was used to 'rescue' these newborns, suggesting it can be effective when other methods fail. Another study mentions that HFJV might be particularly useful when there are major airway problems, which can be a part of diaphragmatic hernia cases. However, more research is needed to fully understand how well HFV works compared to other treatments. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment High Frequency Jet Ventilator and High Frequency Oscillatory Ventilator for diaphragmatic hernia?

Research shows that high frequency ventilation, including both jet and oscillatory types, has been used successfully to help newborns with diaphragmatic hernia when traditional ventilation methods failed. These treatments have also shown promise in managing severe respiratory conditions in both newborns and older children. ^{1 2 3 4 5}

What safety data is available for high frequency ventilation in diaphragmatic hernia treatment?

The provided research does not contain specific safety data for high frequency ventilation treatments such as HFJV or HFOV in the context of diaphragmatic hernia. The studies focus on pharmacovigilance and medical device safety in general, but do not address high frequency ventilation specifically. ^{6 7 8 9 10}

Is High Frequency Jet Ventilator and High Frequency Oscillatory Ventilator a promising treatment for diaphragmatic hernia?

Yes, High Frequency Jet Ventilator (HFJV) and High Frequency Oscillatory Ventilator (HFOV) are promising treatments for diaphragmatic hernia. They have been used successfully to help newborns who did not respond to regular breathing machines. These treatments can improve breathing by using gentle, fast air pulses, which may protect the lungs better and help with breathing problems. ^{1 3 4 5 11}

How is the treatment of high frequency ventilation unique for diaphragmatic hernia?

High frequency ventilation, including high frequency jet ventilation (HFJV) and high frequency oscillatory ventilation (HFOV), is unique because it uses rapid, small breaths to help newborns with diaphragmatic hernia breathe when conventional methods fail. This approach can reduce lung damage and improve gas exchange by using lower pressures, making it a potentially safer option for fragile lungs. ^{1 3 4 5 11}

Research Team

Michelle Yang, MD

Principal Investigator

University of Utah

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Rescue high frequency ventilation for congenital diaphragmatic hernia. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Experimental evaluation of high-frequency jet ventilation. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

High-frequency jet ventilation: theoretical considerations and clinical observations. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

High frequency jet ventilation for congenital diaphragmatic hernia. [2023]

6. Italy pubmed.ncbi.nlm.nih.gov

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

7. New Zealand 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. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. Spain pubmed.ncbi.nlm.nih.gov

Integrating pharmacovigilance into the routine of pharmacy department: experience of nine years. [2020]

10. Switzerland 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. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Long-term high-frequency jet ventilation in neonates. [2019]