Status:
ACTIVE_NOT_RECRUITING
Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode Distance
Lead Sponsor:
Mount Sinai Hospital, Canada
Collaborating Sponsors:
Unity Health Toronto
Conditions:
Respiratory Distress Syndrome, Newborn
Infant, Premature
Eligibility:
All Genders
Phase:
NA
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05427929
Start Date
January 12 2023
End Date
August 1 2025
Last Update
July 8 2025
Active Locations (1)
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1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5