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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
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)
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
549 Previous Clinical Trials
451,064 Total Patients Enrolled
Mount Sinai Hospital, CanadaLead Sponsor
196 Previous Clinical Trials
67,598 Total Patients Enrolled
Amish JainPrincipal InvestigatorMOUNT SINAI HOSPITAL
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a known genetic or chromosomal condition.I do not have any current severe infections or serious bowel and lung conditions.Babies who are not stable from breathing or heart perspectives, as decided by the doctor.My newborn weighs less than 1000g and is on NAVA ventilation.
Research Study Groups:
This trial has the following groups:- Group 1: NVR 4mm Edi Catheter
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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