Status:
COMPLETED
Effect of Changing Levels of Neurally Adjusted Ventilatory Assist (NAVA) in Newborns
Lead Sponsor:
Julie Lefevere
Conditions:
Newborn Morbidity
Eligibility:
All Genders
Up to 20 years
Phase:
NA
Brief Summary
To examine the effect of changing levels of support during NAVA-ventilation ("NAVA-level") on electrical diaphragm activity of the newborn on invasive or non-invasive NAVA ventilation. The aim is to ...
Eligibility Criteria
Inclusion
- Newborns admitted to the NICU in need for respiratory support and put on invasive or non-invasive NAVA by the attending physician. Patients will be included when they are clinically stable and within 24h after starting NAVA or nivNAVA.
Exclusion
- \- Congenital malformations of the diaphragm or respiratory system, including congenital diaphragmatic hernia.
- Patients with abnormalities of the upper airway (e.g. vocal cord paralysis, post-extubation laryngeal edema, Pierre-Robin sequence…).
- More than 20% of time spent in back-up ventilationWhen a patient on NAVA ventilation is apneic for a certain period of time (apnea time), the ventilator switches tot backup-ventilation. Backup-ventilation is pressure controlled, the apnea time can variate between 2 and 10 seconds.
- Clinically unstable patients:
- hemodynamic instability as defined by need of inotropic support or
- rapid respiratory deterioration on NAVA ventilation.
- No informed consent.
Key Trial Info
Start Date :
December 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03780842
Start Date
December 10 2018
End Date
February 28 2022
Last Update
September 13 2023
Active Locations (1)
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1
UZ Brussel
Jette, Belgium, 1090