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

A Pilot Study of Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode Distance

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 < 1000 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Respiratory Distress Syndrome, Newborn; Infant, Premature
• Intervention / Treatment: Device: NVR 4mm Edi catheter

Detailed Description

This is an unblinded pilot study to evaluate the performance of the new 4 mm IED. The procedures required for this evaluation include placement of the new NVR 4 mm Edi catheter, and ventilation in the NAVA mode. All these procedures are considered to have no significant additional risk. Supervision by a physician or respiratory therapist with expertise in Edi catheter and NAVA will be present, in line with the current clinical practice in the Mount Sinai NICU.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Infants deemed to be unstable by the attending clinician from a respiratory or hemodynamic perspective
• Known congenital or chromosomal anomalies
• Any acute illness such as sepsis, necrotizing enterocolitis or acute pulmonary hypertension
• Parental consent not available

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NVR 4mm Edi Catheter	Device: NVR 4mm Edi catheter; Receive NAVA ventilation using the newly designed NVR 4 mm Edi catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of re-initiating NAVA ventilation with new NVR 4mm Edi Catheter	Categorical (yes/no) - Feasibility will be defined as 4mm catheters picking up EDI signals and allowing initiation of NAVA ventilation as per the standard clinical practice. Cases where clinical team is unable to initiate NAVA, necessitating change back to 6 mm catheters will be termed non-feasible.	During study catheter change (total study length = 2 hours during procedure)

Collaborators and Investigators

• Sponsor: Mount Sinai Hospital, Canada
• Collaborators: Unity Health Toronto
• Investigators: Principal Investigator: Amish Jain, Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2023
• Primary Completion (Actual): July 10, 2024
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Preterm Neonates; NAVA Ventilation
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Respiratory Distress Syndrome; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Premature Birth; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: 21-0224-A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No