Clinical Trials Logo

Clinical Trial 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


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05961683
Study type Interventional
Source Keck School of Medicine of USC
Contact Manoj Biniwale
Phone 3234093406
Email Biniwale@usc.edu
Status Not yet recruiting
Phase N/A
Start date August 1, 2023
Completion date September 30, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT01206946 - Efficacy of Antenatal Steroids in Reducing Respiratory Morbidities in Late Preterm Infants Phase 2
Completed NCT00739115 - The Use of Heliox Via Nasal CPAP to Prevent Early CPAP Failure in Premature Infants: A Feasibility Study N/A
Terminated NCT00486395 - Will CPAP Reduce Length Of Respiratory Support In Premature Infants? Phase 3
Completed NCT01242462 - Feasibility of Mid-frequency Ventilation in Newborns With RDS: Randomized Crossover Pilot Trial Phase 1/Phase 2
Enrolling by invitation NCT02050971 - Autologous Cord Blood Infusion for the Prevention and Treatment of Prematurity Complications In Preterm Neonates Phase 1
Completed NCT00486850 - Synchronized Intermittent Mandatory Ventilation (SIMV) Versus Nasal Intermittent Positive Pressure Ventilation (NIPPV) In Preterm Infants With Respiratory Distress Phase 4
Terminated NCT00005776 - Inhaled Nitric Oxide Study for Respiratory Failure in Newborns Phase 3
Completed NCT04500353 - Routine Or Selective Application of a Face Mask for Preterm Infants at Birth: the ROSA Trial N/A
Completed NCT05796128 - NIPPV vs.nCPAP During LISA Procedure N/A
Withdrawn NCT02835209 - Positioning During SBT in NICU Infants N/A
Terminated NCT01467076 - Inhaled Prostaglandin E1 (IPGE1) for Hypoxemic Respiratory Failure (NHRF) Phase 2
Completed NCT00556738 - Intrapulmonary Percussive Ventilation (IPV) Versus Nasal Continuous Positive Airway Pressure Ventilation (nCPAP) in Transient Respiratory Distress of the Newborn N/A
Completed NCT00828243 - Genetic Regulation of Surfactant Deficiency
Not yet recruiting NCT05594030 - Thoracic Fluid Content by Electric Bioimpedance Versus Lung Ultrasound in Preterm Neonates With Respiratory Distress
Completed NCT02332304 - Amniotic Fluid Optical Density Determination as a Test for Assessment of Fetal Lung Maturity. Phase 3
Withdrawn NCT00598429 - Inhaled PGE1 in Neonatal Hypoxemic Respiratory Failure Phase 2
Completed NCT04137783 - ABCA3 Gene and RDS in Late Preterm and Term Infants
Completed NCT01941524 - Brain Oxygenation and Function of Preterm Newborns During Administration of Two Different Surfactant Preparations Phase 4
Completed NCT01102543 - Observational Study on the Prophylactic Use of Curosurf in Neonatal Respiratory Distress Syndrome (RDS) N/A
Completed NCT00501982 - Efficacy of Combining Prophylactic Curosurf With Early Nasal CPAP in Delivery Room: the Curpap Study Phase 4