Evaluating Pressures During Non-invasive Ventilation Utilizing NIV Plus Software

Launched by KECK SCHOOL OF MEDICINE OF USC · Jul 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new software feature on Medtronic PB980 ventilators designed to improve the treatment of newborns with breathing difficulties, specifically those with respiratory distress syndrome or apnea. The software, called NIV plus with leak sync, helps measure the actual pressure delivered to a baby's nostrils during non-invasive ventilation (NIV). This is important because sometimes, due to leaks or resistance in the equipment, the pressure that reaches the baby can be lower than what is set on the machine. The trial aims to understand how effective this new technology is at ensuring that newborns receive the right amount of pressure for safe and effective treatment.

To be eligible for this trial, babies must be between 23 to 41 weeks of gestation, born at LAC+USC Medical Center, and admitted to the Neonatal Intensive Care Unit (NICU) to receive either non-invasive positive pressure ventilation (NIPPV) or nasal continuous positive airway pressure (CPAP). Unfortunately, babies with certain medical conditions, those receiving only comfort care, or those who are already intubated cannot participate. If enrolled, participants will be monitored for their breathing, heart rate, and how well the new software works in delivering the needed pressure while receiving NIV treatment. This study is a promising step in improving care for vulnerable newborns.

Gender

ALL

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