Phase 2
N=24
Randomized Crossover Study of Neurally Adjusted Ventilatory Assist (NAVA) in Preterm Infants
Infant, Preterm
Bottom Line
View on ClinicalTrials.gov: NCT01389882 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Oct 2011
Primary outcome: Primary: Peak Inspiratory Pressure — 13.45; 12.45 cmH2O — p=0.043
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- neurally adjusted ventilatory assist (NAVA) ventilator mode (Procedure)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Seoul National University Hospital
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Inspiratory Pressure |
13.45; 12.45 | 0.043 sig |
| SECONDARY Mean Airway Pressure |
7.99; 8.02 | 0.245 |
| SECONDARY Minute Ventilation |
0.53; 0.51 | 0.257 |
| SECONDARY Expiratory Tidal Volume |
8.73; 8.54 | 0.601 |
| SECONDARY Dynamic Compliance |
1.70; 1.84 | 0.085 |
| SECONDARY Work of Breathing |
11.13; 8.38 | 0.002 sig |
| SECONDARY Peak EAdi |
13.39; 11.70 | 0.009 sig |
| SECONDARY Fraction of Oxygen |
23.33; 23.47 | 0.314 |
| SECONDARY Capillary Blood pH |
7.327; 7.334 | 0.515 |
| SECONDARY Capillary Blood pCO2 |
46.75; 46.64 | 0.949 |
| SECONDARY Capillary Blood pO2 |
38.89; 37.84 | 0.709 |
| SECONDARY Capillary Blood HCO3 |
24.46; 24.74 | 0.600 |
Summary
The purpose of this study is to test the hypothesis that neurally adjusted ventilatory assist (NAVA) will allow to lower the ventilator pressure at equivalent fractions of inspiratory oxygen (FiO2) and partial pressure of CO2 of capillary blood in preterm infants in comparison with currently used standard ventilation (synchronized intermittent mandatory ventilation with pressure-support ventilation, SIMV+PSV).
Eligibility Criteria
Inclusion Criteria
- preterm infants mechanically ventilated
- ventilatory set frequency is under 25
- with informed consent of their parents
Exclusion Criteria
- major congenital anomalies
- patients without self respiratory effort
- use of sedative or anesthetic drugs
- grade III or IV intraventricular hemorrhage
- phrenic nerve palsy or insufficiency
Data sourced from ClinicalTrials.gov (NCT01389882). 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.