An interventional study of Drager VN500 Ventilator in Respiratory Distress Syndrome, Newborn and Chronic Lung Disease of Newborn (Diagnosis), sponsored by University of British Columbia. Status unknown at 1 site in Canada. Open to participants aged 48 Hours to 90 Days. Per ClinicalTrials.gov, last updated 2019-04-17.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
Preterm babies have immature lungs and frequent pauses in their breathing which often necessitates breathing support. Nasal Continuous Positive Airway Pressure (CPAP) is one of the most commonly used tools but does not always provide enough support. A new option is non-invasive high frequency ventilation (NHFOV), which gently shakes the lungs to help with gas exchange and may decrease a baby's work of breathing. The investigators plan to study very low birth weight preterm babies who are generally well but require some support with their breathing. By inserting a special feeding tube with sensors into the stomach, the investigators can measure the electrical activity of the diaphragm (EAdi), which is an important muscle for breathing. By analyzing EAdi in babies receiving either CPAP or NHFOV, the investigators will be able to measure and compare how each method of support affects a baby's breathing. This important study will help us determine the most appropriate breathing support for preterm babies.
Continuous Positive Airway Pressure is one of the most researched and accepted methods of delivering NIV to term and preterm infants. Non-invasive high frequency ventilation is a relatively new method of delivering NIV respiratory support in preterm infants. Preliminary studies suggest superiority over CPAP, and NHFOV is being increasingly utilized in clinical practice in an attempt to prevent intubation and minimize ventilation-induced lung injury in preterm infants. However, little is known about its mechanism of action and its effect on respiratory mechanics in the newborn. The objective of this study is to compare the effects of non-invasive ventilation (NIV) delivered by nasal Continuous Positive Airway Pressure (CPAP) versus Non-Invasive High Frequency Ventilation (NHFOV) on respiratory pattern as assessed by the electrical activity of the diaphragm (EAdi) in very low birth weight (VLBW) preterm infants.
The investigators hypothesize that in VLBW preterm infants with relative pulmonary insufficiency, NHFOV will reduce respiratory drive and improve ventilation, subsequently resulting in decreased patient diaphragm energy expenditure. This would be demonstrated by decreased neural respiratory rates and/or decreased peak electrical activity of the diaphragm while breathing on NHFOV compared to CPAP.
Clinicians are seeking alternative methods for providing non-invasive respiratory support to preterm infants. NHFOV is a relatively new modality that is being increasingly utilized in clinical practice but has not been well studied. This study will help the investigators determine how non-invasive high frequency ventilation affects breathing in preterm infants, as compared to the more traditional modality of nasal CPAP. Therefore, clinicians will not only be able to better understand how NHFOV works, but also utilize this information to decide on the most appropriate respiratory support modality for preterm patients
123 studies on the registry are indexed under Respiratory Distress Syndrome, Newborn; 24 are open to participants now.
This study's planned enrollment of 20 is below the median of 90 across 93 interventional studies indexed under Respiratory Distress Syndrome, Newborn.
Browse Respiratory Distress Syndrome, Newborn studies →University of British Columbia is the lead sponsor of 1,339 studies on the registry; 259 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Nasal continuous positive airway pressure is a frequently used modality for non-invasive respiratory support in preterm infants. Intervention: Device: Drager VN500 Ventilator
Device: Drager VN500 Ventilator
Non-invasive high-frequency ventilation is a relatively new modality that is being utilized to support preterm infants and prevent the need for invasive ventilation, but this particular modality has not been well studied to date. Intervention: Device: Drager VN500 Ventilator
Device: Drager VN500 Ventilator
This ventilator is capable of providing both CPAP and NHFOV support.
The difference in the peak electrical activity of the diaphragm between CPAP and NHFOV.
Measured by the electrical activity of the diaphragm between respiratory support modes (CPAP and NHFOV).
Time frame: 4 hours
Difference in neural respiratory rate.
Measured by the electrical activity of the diaphragm between respiratory support modes (CPAP and NHFOV).
Time frame: 4 hours
Difference in neural inspiratory time.
Measured by the electrical activity of the diaphragm between respiratory support modes (CPAP and NHFOV).
Time frame: 4 hours
Difference in diaphragm energy expenditure.
Measured by the electrical activity of the diaphragm between respiratory support modes (CPAP and NHFOV).
Time frame: 4 hours
Difference in transcutaneous pCO2 on the different modes of non-invasive ventilation.
TpCO2 bedside measurement.
Time frame: 4 hours
Difference in the number of apnea episodes.
Clinical monitoring and vitals monitoring at the bedside.
Time frame: 4 hours
Differences in SpO2 histogram classification between modes of ventilation.
Electronic vitals monitoring.
Time frame: 4 hours
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jul 2018 (actual). Primary completion is estimated for Dec 2019, 17 months after the start.
Of 35 non-industry interventional studies with no phase under Respiratory Distress Syndrome, Newborn, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 40. This study's planned 17 months is below that.
Counting every sponsor, half of 35 studies reached it within 23 months; a quarter within 13 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Respiratory Distress Syndrome, Newborn →
University of British Columbia →