Does Non-Invasive Ventilation Neurally-Adjusted Ventilatory Assist (NIV-NAVA) Improve Diaphragmatic Function in Preterm Infants?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mount Sinai Hospital, Canada
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Evaluation of the diaphragmatic Thickness (in millimetre) in neonates on each arm (NIV-NAVA and NIPPV)
Study Overview
Brief Summary
Non-Invasive Positive Pressure Ventilation (NIPPV) provides un-synchronized positive pressure and considered to be superior to nCPAP in preventing extubation failure. Recently, Non-Invasive Ventilation Neurally-Adjusted Ventilatory Assist (NIV-NAVA) was introduced to NICU. NAVA is a ventilation mode that uses the electrical activity of the patient's diaphragm (Edi-signal) to guide both timing and magnitude of the support. However, it is unknown whether NIV-NAVA is superior to NIPPV in preventing extubation failure and preventing BPD.
Hence, the investigators aim to compare the effect of NIPPV and NIV-NAVA on diaphragm function in premature infants with RDS or evolving BPD. Our hypothesis is that infants treated with NIV-NAVA will have improved diaphragmatic function and lung scoring.
Detailed Description
STUDY POPULATION Premature infants with respiratory distress syndrome who are admitted to Mount Sinai NICU and are supported with NIPPV or NIV-NAVA.
Inclusion criteria
- Infants that were born at 22 0/7 to 29 6/7 weeks gestation and admitted to the NICU at Mount Sinai Health System.
- Infants that are on NIPPV or NIV-NAVA respiratory support for at least 24 hours at the time of enrolment.
Exclusion criteria
- Infants with congenital anomalies.
- Infants with known genetic disorder.
- Infants with known lung malformation or diaphragm dysfunction.
- Infants of whom parents declined consent.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 2 Weeks to 4 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Infants with congenital anomalies.
- •Infants with known genetic disorder.
- •Infants with known lung malformation or diaphragm dysfunction.
- •Infants of whom parents declined consent.
Outcomes
Primary Outcomes
Evaluation of the diaphragmatic Thickness (in millimetre) in neonates on each arm (NIV-NAVA and NIPPV)
Time Frame: 1 YEAR
Chest ultrasound will be performed to eligible (consented) patient after being on the respiratory support (NIV-NAVA vs NIPPV) for at least 24 hours. diaphragmatic Thickness (in millimetre) will be measured. Investigator interpreting the scans will be blind to patients type of respiratory support or clinical status.
Evaluation of the diaphragmatic excursion (in millimetre) in neonates on each arm (NIV-NAVA and NIPPV)
Time Frame: 1 YEAR
Chest ultrasound will be performed to eligible (consented) patient after being on the respiratory support (NIV-NAVA vs NIPPV) for at least 24 hours. diaphragmatic Excursion (in millimetre) will be measured. Investigator interpreting the scans will be blind to patients type of respiratory support or clinical status.
Secondary Outcomes
- Lung ultrasound score for infants in NIV-NAVA group vs NIPPV group(1 YEAR)
Investigators
Adel Mohamed
Principal Investigator
Mount Sinai Hospital, Canada