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NIV Plus Software for Neonatal Respiratory Distress Syndrome

N/A
Waitlist Available
Research Sponsored by Keck School of Medicine of USC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Received NIPPV or nasal CPAP
Be younger than 18 years old
Must not have
Infants receiving invasive mode of mechanical ventilation (intubated)
Non-inborn neonates
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights

Summary

This trial is looking at whether a new software can help babies with respiratory distress by measuring the air pressure at their nostrils & provide safe, effective therapy.

Who is the study for?
This trial is for newborns born at LAC+USC Medical Center and admitted to the NICU, with a gestational age between 23-41 weeks, who are receiving non-invasive positive pressure ventilation (NIPPV) or nasal CPAP. It excludes those intubated, not born in this center, on comfort care only, readmitted to NICU, or with congenital anomalies.Check my eligibility
What is being tested?
The study tests Medtronic PB980 ventilators' NIV plus and leak sync software that measures pressures delivered at the nostrils during non-invasive ventilation. The goal is to determine optimal pressures for safe and effective therapy by monitoring various outcomes like apnea and need for increased support.See study design
What are the potential side effects?
While specific side effects aren't listed for this device trial, potential risks may include discomfort from the mask fit or skin irritation around the nostrils due to equipment use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have used a CPAP or similar device for breathing support.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My infant is on a breathing machine.
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I am not a newborn baby.
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My infant is only receiving comfort care.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
interventions performed while using NIV plus software
Secondary outcome measures
difference in pressures set and received

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Infants receiving non invasive ventilation with NIV plusExperimental Treatment1 Intervention
Group II: Infants receiving non invasive ventilation without NIV plusActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Keck School of Medicine of USCLead Sponsor
5 Previous Clinical Trials
610 Total Patients Enrolled
MedtronicIndustry Sponsor
611 Previous Clinical Trials
828,789 Total Patients Enrolled

Media Library

Infants receiving non invasive ventilation with NIV plus Clinical Trial Eligibility Overview. Trial Name: NCT05961683 — N/A
Neonatal Respiratory Distress Syndrome Research Study Groups: Infants receiving non invasive ventilation with NIV plus, Infants receiving non invasive ventilation without NIV plus
Neonatal Respiratory Distress Syndrome Clinical Trial 2023: Infants receiving non invasive ventilation with NIV plus Highlights & Side Effects. Trial Name: NCT05961683 — N/A
Infants receiving non invasive ventilation with NIV plus 2023 Treatment Timeline for Medical Study. Trial Name: NCT05961683 — N/A
~52 spots leftby Jul 2025
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