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Clinical Trials/NCT05961683
NCT05961683
Not yet recruiting
Not Applicable

Evaluating Pressures at the Nares During Non-invasive Ventilation in Newborn Infants Utilizing NIV Plus Software

Keck School of Medicine of USC1 site in 1 country100 target enrollmentAugust 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Distress Syndrome, Newborn
Sponsor
Keck School of Medicine of USC
Enrollment
100
Locations
1
Primary Endpoint
interventions performed while using NIV plus software
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
August 1, 2023
End Date
September 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Manoj Biniwale

Associate Professor of Pediatrics

Keck School of Medicine of USC

Eligibility Criteria

Inclusion Criteria

  • Gestation Age of 23-41 weeks
  • Born at LAC+USC Medical Center and admitted to NICU
  • Received NIPPV or nasal CPAP

Exclusion Criteria

  • Infants with any congenital anomalies
  • Infants receiving only comfort care measures.
  • Infants receiving invasive mode of mechanical ventilation (intubated)
  • Non-inborn neonates
  • Re-admissions to the NICU

Outcomes

Primary Outcomes

interventions performed while using NIV plus software

Time Frame: 24 hours

will study the number of interventions performed when NIV plus software is used

Secondary Outcomes

  • difference in pressures set and received(12 hours)

Study Sites (1)

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