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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
Neonates with current weight <1000g who are already receiving invasive or non-invasive NAVA ventilatory support using the standard 6 mm IED Edi catheter will be eligible for recruitment.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My newborn weighs less than 1000g and is on NAVA ventilation.

Timeline

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

Find a Location

Who is running the clinical trial?

Unity Health TorontoOTHER
536 Previous Clinical Trials
447,519 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
~4 spots leftby Apr 2025