Phase 3
N=16
Physiologic Comparison Between NIV-NAVA and PS in Preterm Infants
Noninvasive Neurally Adjusted Ventilatory Assist and Pressure Support in Preterm Infants
Bottom Line
View on ClinicalTrials.gov: NCT01877720 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: Primary: Trigger Delay — 35.2; 294.6 ms — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- noninvasive respiratory support with NAVA mode and PSV (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Seoul National University Hospital
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trigger Delay |
35.2; 294.6 | <0.001 sig |
| SECONDARY Ti_excess (Inspiratory Time in Excess) |
32.2; 56.8 | 0.001 sig |
| SECONDARY Minute Ventilation Volume |
114.9; 124.1 | 0.74 |
| SECONDARY Peak Inspiratory Pressure |
12.3; 14.7 | 0.003 sig |
| SECONDARY Pneumatic Respiratory Rate |
46.3; 33.3 | 0.002 sig |
| SECONDARY Maximum EAdi |
12.6; 16.6 | 0.003 sig |
| SECONDARY Swing EAdi |
8.8; 12.2 | 0.012 sig |
| SECONDARY Leakage |
87.6; 86.7 | 0.67 |
| SECONDARY All Asynchrony Events |
8.2; 47.6 | <0.001 sig |
| SECONDARY Asynchrony Index |
19.7; 73.9 | <0.001 sig |
| SECONDARY SpO2 |
— | — |
| SECONDARY Heart Rate |
— | — |
| SECONDARY Blood Pressure |
— | — |
| SECONDARY Respiratory Rate |
— | — |
Summary
Neurally adjusted ventilatory assist (NAVA) has been shown to improve patient- ventilator interaction and reduce asynchronies. This is a short-term physiologic comparison between PSV (pressure support ventilation) and NAVA in delivering noninvasive ventilation through a nasal cannula, in premature infants postextubation. Patients will undergo a 30-min crossover trial of noninvasive PSV and NAVA, 15 minutes each. Diaphragm electrical activity (EAdi)and airway pressure (Paw) are recorded to derive neural and mechanical respiratory rate and timing, inspiratory trigger delays time of synchrony between diaphragm contraction and ventilator assistance, and the asynchrony index (AI).
Eligibility Criteria
Inclusion Criteria
- preterm infants less than 32 weeks of gestational age
- intubated more than 48 hours after birth
- subjected to extubation with minimal ventilator setting (mean airway pressure < 7cmH2O + peak inspiratory pressure < 13 cmH2O + FiO2 < 0.4 + respiratory rate < 35/min)
- with informed consent from parents
Exclusion Criteria
- with major congenital anomalies
- use of sedative or anesthetic drugs
- hemodynamic instability
- grade 3 or higher intraventricular hemorrhage
- phrenic nerve palsy
Data sourced from ClinicalTrials.gov (NCT01877720). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.