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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours

Awards & highlights

Study 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

Select...

I have used a CPAP or similar device for breathing support.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours

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

0 / 1Eligibility criteria met

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

605 Previous Clinical Trials

828,095 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the minimum age requirement for this clinical trial 18 or above?

"This clinical trial is actively seeking participants that are between 0 and 30 days of age."

Answered by AI

Am I able to join this clinical study?

"In order to be approved for the trial, neonates with respiratory distress syndrome must fall between 0 days and 30 days of age. This experiment is currently looking for 100 participants in total."

Answered by AI

Is enrollment still available in this experiment?

"As per the details on clinicaltrials.gov, this particular medical trial is not open to new participants at present. The research was first posted on August 1st 2023 and last updated July 18th 2023. Nevertheless, 182 other studies are actively accepting volunteers currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluating Pressures During Non-invasive Ventilation Utilizing NIV Plus Software

Manoj Biniwale 2023. "Evaluating Pressures During Non-invasive Ventilation Utilizing NIV Plus Software". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05961683.