Evaluating Pressures During Non-invasive Ventilation Utilizing NIV Plus Software
Primary Purpose
Respiratory Distress Syndrome, Newborn, Apnea of Newborn
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NIV plus software
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Distress Syndrome, Newborn
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
Sites / Locations
- Los Angeles General Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Infants receiving non invasive ventilation without NIV plus
Infants receiving non invasive ventilation with NIV plus
Arm Description
Outcomes
Primary Outcome Measures
interventions performed while using NIV plus software
will study the number of interventions performed when NIV plus software is used
Secondary Outcome Measures
difference in pressures set and received
will study the pressure difference as calculated by NIV plus software
Full Information
NCT ID
NCT05961683
First Posted
July 18, 2023
Last Updated
July 18, 2023
Sponsor
Keck School of Medicine of USC
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT05961683
Brief Title
Evaluating Pressures During Non-invasive Ventilation Utilizing NIV Plus Software
Official Title
Evaluating Pressures at the Nares During Non-invasive Ventilation in Newborn Infants Utilizing NIV Plus Software
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Keck School of Medicine of USC
Collaborators
Medtronic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Newborn, Apnea of Newborn
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Infants receiving non invasive ventilation without NIV plus
Arm Type
No Intervention
Arm Title
Infants receiving non invasive ventilation with NIV plus
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
NIV plus software
Intervention Description
interventions received by infants studied after placing them on ventilator using NIV plus software
Primary Outcome Measure Information:
Title
interventions performed while using NIV plus software
Description
will study the number of interventions performed when NIV plus software is used
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
difference in pressures set and received
Description
will study the pressure difference as calculated by NIV plus software
Time Frame
12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manoj Biniwale
Phone
3234093406
Email
Biniwale@usc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rangasamy Ramanathan
Phone
3234093406
Email
Ramanath@usc.edu
Facility Information:
Facility Name
Los Angeles General Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Evaluating Pressures During Non-invasive Ventilation Utilizing NIV Plus Software
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