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Device

Smaller Diaphragm Monitoring Catheter for Premature Infants with Respiratory Distress

N/A

Recruiting

Led By Amish Jain

Research Sponsored by Mount Sinai Hospital, Canada

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during study catheter change (total study length = 2 hours during procedure)

Awards & highlights

Study Summary

This trial will test a new, smaller tube to help very premature babies who are on NAVA ventilation. The new tube is 4 mm instead of 6 mm, with all other parameters the same. The study will use 10 babies who are already receiving NAVA ventilation.

Who is the study for?

This trial is for extremely premature neonates under 1000g already on NAVA ventilation. It's not for those with congenital anomalies, without parental consent, or suffering from acute illnesses like sepsis or unstable in terms of breathing or blood circulation.Check my eligibility

What is being tested?

The study tests a new prototype Edi catheter designed for the tiniest babies on ventilators. The new catheter has sensors closer together (4mm apart) to better fit and function in these small patients compared to the standard one.See study design

What are the potential side effects?

No significant side effects have been observed with the current standard catheter; however, this trial will monitor any potential issues arising from using the newly designed smaller sensor-equipped catheter.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during study catheter change (total study length = 2 hours during procedure)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during study catheter change (total study length = 2 hours during procedure)

This trial's timeline: 3 weeks for screening, Varies for treatment, and during study catheter change (total study length = 2 hours during procedure) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of re-initiating NAVA ventilation with new NVR 4mm Edi Catheter

Trial Design

1Treatment groups

Experimental Treatment

Group I: NVR 4mm Edi CatheterExperimental Treatment1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Unity Health TorontoOTHER

539 Previous Clinical Trials

447,755 Total Patients Enrolled

Mount Sinai Hospital, CanadaLead Sponsor

196 Previous Clinical Trials

67,598 Total Patients Enrolled

Amish JainPrincipal InvestigatorMOUNT SINAI HOSPITAL

Media Library

NVR 4mm Edi catheter (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05427929 — N/A

Neonatal Respiratory Distress Syndrome Research Study Groups: NVR 4mm Edi Catheter

Neonatal Respiratory Distress Syndrome Clinical Trial 2023: NVR 4mm Edi catheter Highlights & Side Effects. Trial Name: NCT05427929 — N/A

NVR 4mm Edi catheter (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05427929 — N/A

Frequently Asked Questions

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

Are there open slots available for enrolment in this trial?

"Clinicaltrials.gov indicates that this trial is actively seeking participants as of now, with the first post being made on October 1st 2022 and a recent update occurring on September 26th 2022."

Answered by AI

How many people have enrolled in this research initiative?

"Affirmative. Information on clinicaltrials.gov supports the active recruitment of this medical experiment, which was published on October 1st 2022 and revised as recently as September 26th 2022. In total, 10 participants are required from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode Distance

2023. "Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode Distance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05427929.