High Frequency Ventilation for Diaphragmatic Hernia
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byMichelle Yang, MD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Utah
No Placebo Group
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.
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.
12345What 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.
678910Is 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.
134511Eligibility 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
+2 more
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
+3 more
Participant Groups
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.
4Treatment groups
Active Control
Group I: High Frequency Oscillatory Ventilation (HFOV) without intrathoracic liverActive Control1 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 liverActive Control1 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 liverActive Control1 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 liverActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University HospitalSalt Lake City, UT
Primary Children's HospitalSalt Lake City, UT
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Who Is Running the Clinical Trial?
University of UtahLead Sponsor
References
Rescue high frequency ventilation for congenital diaphragmatic hernia. [2020]High frequency jet (HFJV) and oscillatory (HFOV) ventilation were used to rescue newborns with congenital diaphragmatic hernia (CDH), who failed conventional mechanical ventilation (CV). Changes in ventilator settings and pulmonary gas exchange were evaluated following transition to high frequency ventilation (HFV).
Experimental evaluation of high-frequency jet ventilation. [2019]The consensus of available studies indicates that high-frequency jet ventilation (HFJV) can adequately ventilate animals in respiratory failure, although a clear superiority to volume-cycled ventilation (VCV) cannot be established. HFJV is probably useful in the presence of airway disruption and in tracheal or pulmonary surgery. Clinical trials and additional bench and animal studies must be performed, to reach a full understanding of the potential benefits of this technique.
High-frequency jet ventilation for severe respiratory failure. [2005]High-frequency jet ventilation (HFJV) is a newer form of mechanical ventilatory support that has shown promise in the treatment of severe neonatal respiratory distress syndrome. It is now also being studied as a possible treatment for adult respiratory distress syndrome in older children.
High-frequency jet ventilation: theoretical considerations and clinical observations. [2019]High-frequency jet ventilation (HFJV) described a technique of mechanical respiratory support based on the delivery of gases under conditions of constant flow and low pressure. Among the benefits ascribed to HFJV are lessened interference with hemodynamic function and reduced danger of barotrauma. The theoretical and technical aspects of HFJV are discussed and the clinical experience with 39 patients in respiratory failure reported. Synchronization of HFMV with heart rate was attempted in three patients. Cardiac output and ejection fraction increased in all of them. At present, results suggest that HFJV may be the ideal form of support for patients with major airway disruption. The available data also indicated that extensive clinical trials are warranted to define advantages and limits of this form of ventilation.
High frequency jet ventilation for congenital diaphragmatic hernia. [2023]The optimal role of high frequency jet ventilation (HFJV) in lung protective stabilization of congenital diaphragmatic hernia (CDH) remains uncertain. We aimed to describe our center's experience with HFJV as both a rescue (following failed stabilization with CMV) and primary ventilation mode in the management of CDH.
[Pharmacovigilance: education and continuing updating. The role of university institutes]. [2013]Lately, pharmacovigilance (FV) and monitoring of adverse reactions to drugs are a frequent issue of analysis and discussion due the prospective alignment of Italian FV with the European Community (EC) guidelines.
Evaluation of completeness of suspected adverse drug reaction reports submitted to the mexican national pharmacovigilance centre: a cross-sectional period-prevalence study. [2021]The Mexican National Centre of Pharmacovigilance (CNFV) receives suspected adverse drug reaction (ADR) reports from the pharmaceutical industry, Federal States Centre of Pharmacovigilance (CEFV) and Healthcare Institution Centres of Pharmacovigilance (CIFV). The completeness of these suspected ADR reports is particularly important for the proper evaluation of drug safety.
Anaesthesia equipment safety in Canada: the role of government regulation. [2018]Medical device problems as detected by the Health Protection Branch (HPB) of Health and Welfare Canada were studied in order to examine the frequency and safety priority of problems in the subgroup of anaesthesia devices. Data pertaining to the time period from April 1, 1987 to November 30, 1992 were gathered from the Medical Devices Notification Database and the DAFFY Reporting System. The Medical Devices Notification Database contains all notifications for newly marketed medical devices in Canada and the DAFFY Reporting System keeps record of all submitted problem reports and manufacturer recalls along with their designated safety priority status. When an important safety hazard is associated with a medical device as determined from information submitted to HPB, an Alert-Medical Devices may be issued to inform hospitals and health care professionals of the problem. During the studied time period, the percentages of problem reports and recalls as well as Alerts were compared with the percentage of newly marketed anaesthesia devices. It was found that although only 2.3% of the newly marketed medical devices were classified as anaesthesia devices, 8.6% of all problem reports/recalls and 37.5% of all Alerts originated from the field of anaesthesia devices. Comparison of the percentages of problem reports/recalls (8.6%) and Alerts (37.5%) with the percentage of marketed devices for anaesthesia (2.3%) showed differences (P
Integrating pharmacovigilance into the routine of pharmacy department: experience of nine years. [2020]To describe our pharmacovigilance program and to analyze the reported adverse drug reactions.
Drug-Induced Acute Kidney Injury: A Study from the French Medical Administrative and the French National Pharmacovigilance Databases Using Capture-Recapture Method. [2021]Acute kidney injury (AKI) is a public health concern. Among the pathological situations leading to AKI, drugs are preventable factors but are still under-notified. We aimed to provide an overview of drug-induced AKI (DIAKI) using pharmacovigilance and medical administrative databases Methods: A query of the PMSI database (French Medical Information System Program) of adult inpatient hospital stays between 1 January 2017 and 31 December 2018 was performed using ICD-10 (International Classification of Diseases 10th revision) codes to identify AKI cases which were reviewed by a nephrologist and a pharmacovigilance expert to identify DIAKI cases. In parallel, DIAKIs notified in the French Pharmacovigilance Database (FPVDB) were collected. A capture-recapture method was performed to estimate the total number of DIAKIs.
Long-term high-frequency jet ventilation in neonates. [2019]High-frequency jet ventilation (HFJV) markedly improved the ventilatory status of 2 neonates with severe respiratory failure refractory to conventional mechanical ventilatory support. However, after approximately 1 wk of HFJV, both patients expired from causes not directly related to ventilatory compromise. Autopsy showed no gross alterations in tracheal or bronchial mucosa but did reveal microscopic lesions which could be attributable to HFJV.