NVR 4mm Edi Catheter for Respiratory Distress Syndrome, Newborn

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mount Sinai Hospital, Toronto, Canada
Respiratory Distress Syndrome, Newborn+2 More
NVR 4mm Edi catheter - Device
Eligibility
Any Age
All Sexes
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Study Summary

Neurally Adjusted Ventilatory Assist (NAVA) is a mode of ventilation where the electrical activity of the diaphragm (EDI) - a signal representing the baby's respiratory drive - is used to control the timing and amount of assist provided. NAVA was introduced to the market in 2007 and since has been used in more than 40 countries. In the current clinical practice, the Edi signal from the patient is captured with miniature sensors (the size of a hair) embedded in the wall of a specially designed naso/orogastric feeding tube. This FDA and Health Canada approved, commercially available catheter (Getinge, Solna, Sweden), is 6 Fr in size (outer diameter), 49 cm in length and has 8 pairs of sensors that are placed 6 mm apart (so-called inter electrode distance (IED) is 6 mm). While no obvious side effects have been noted by clinicians, for the smallest of neonates, the currently used commercial catheter (size 6F, 49 cm long) may have 'excessive' post-array catheter length. In these neonates, typically those with weight < 750 grams, following the correct placement of catheter as per the electrode array positioning at gastro-esophageal junction, the feeding holes in the catheter may end at the level of distal stomach instead of the desirable mid-stomach location. The changing demographics of the patients in the Neonatal Intensive Care Units (NICU) has created a clinical need to redesign the currently used Edi catheter specifically to suit the smallest of patients, such that following adequate placement the feeding holes sit at the level of mid-stomach. Drs. Christer Sinderby and Jennifer Beck in Toronto, Canada, are the original designers of the 6 mm/49 cm currently used Edi catheter. These investigators (at St-Michael's Hospital, Toronto) in collaboration with their team at Neurovent Research Inc. (NVR) have re-designed and invented a new prototype of the current FDA-approved catheter specifically suited for use in extreme premature neonates. They have done so by reducing the interelectrode distance from the originally set 6 mm to 4 mm, which reduces the overall insertion depth to capture the same signal from the diaphragm. All other parameters are exactly same as the original catheter (6F, 49 cm long). In this small feasibility study the investigators wish to provide a clinical proof of concept for the use of this newly designed prototype in 10 extremely premature neonates who are already receiving NAVA ventilation in the NICU.

Eligible Conditions

  • Respiratory Distress Syndrome, Newborn
  • Infants, Premature

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Respiratory Distress Syndrome, Newborn

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: During study catheter change (total study length = 2 hours during procedure)

Hour 2
Feasibility of re-initiating NAVA ventilation with new NVR 4mm Edi Catheter

Trial Safety

Safety Progress

1 of 3

Other trials for Respiratory Distress Syndrome, Newborn

Trial Design

1 Treatment Group

NVR 4mm Edi Catheter
1 of 1
Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: NVR 4mm Edi Catheter · No Placebo Group · N/A

NVR 4mm Edi Catheter
Device
Experimental Group · 1 Intervention: NVR 4mm Edi catheter · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: during study catheter change (total study length = 2 hours during procedure)
Closest Location: Mount Sinai Hospital · Toronto, Canada
Photo of Toronto  1Photo of Toronto  2Photo of Toronto  3
2011First Recorded Clinical Trial
3 TrialsResearching Respiratory Distress Syndrome, Newborn
493 CompletedClinical Trials

Eligibility Criteria

Age Any Age · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.