Evaluating Pressures During Non-invasive Ventilation Utilizing NIV Plus Software

Respiratory Distress Syndrome, Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05961683
• Other study ID #: 13192
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: July 2023
• Source: Keck School of Medicine of USC
• Contact: Manoj Biniwale
• Phone: 3234093406
• Email: Biniwale[@]usc.edu
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 30 Days

Eligibility

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

Related Conditions & MeSH terms

• Apnea of Newborn
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• NIV plus software
interventions received by infants studied after placing them on ventilator using NIV plus software

Locations

Country	Name	City	State
United States	Los Angeles General Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Keck School of Medicine of USC	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	interventions performed while using NIV plus software	will study the number of interventions performed when NIV plus software is used	24 hours
Secondary	difference in pressures set and received	will study the pressure difference as calculated by NIV plus software	12 hours