An interventional study of NIV plus software in Respiratory Distress Syndrome, Newborn and Apnea of Newborn, sponsored by Keck School of Medicine of USC. Status unknown at 1 site in United States. Open to participants aged 0 Days to 30 Days. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by Keck School of Medicine of USC · Not applicable, Interventional, and Treatment
In the past many neonates with respiratory distress syndrome would require intubation, but over the years these rates have declined as the capabilities of non-invasive ventilation (NIV) have vastly improved. Despite these improvements, the decrease in pressure transmission due to factors such as resistance from tubing or air leaks around the nostrils and mouth, continues to be one of the major drawbacks when using nasal NIV. Current ventilators measure the set pressures at the circuit but do not capture the delivered pressure at the patient's nares. Recently, Medtronic PB980 ventilators feature NIV plus and leak sync software that can be calibrated to measure the pressures provided at the nostrils. Optimum pressures received at the nostrils to provide safe and effective therapy in neonates is currently unknown. In the prospective portion of the study, we aim to evaluate safety and efficacy of the software by comparing the average pressure difference between the circuit and delivery pressure at the nares, the incidence of apnea, bradycardia, desaturations as well as escalation and de-escalation of ventilator support in newborns who are receiving NIV admitted to NICU
1,179 studies on the registry are indexed under Respiratory Distress Syndrome, Newborn; 160 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 714 interventional studies indexed under Respiratory Distress Syndrome, Newborn.
Browse Respiratory Distress Syndrome, Newborn studies →Keck School of Medicine of USC is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
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:
Device: NIV plus software
interventions received by infants studied after placing them on ventilator using NIV plus software
interventions performed while using NIV plus software
will study the number of interventions performed when NIV plus software is used
Time frame: 24 hours
difference in pressures set and received
will study the pressure difference as calculated by NIV plus software
Time frame: 12 hours
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Aug 2023; primary completion for Jun 2024, 10 months later.
Of 234 non-industry interventional studies with no phase under Respiratory Distress Syndrome, Newborn, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 10 months is below that.
Counting every sponsor, half of 238 studies reached it within 22 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2023. 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 →
Keck School of Medicine of USC