Randomised crossover trial of neurally adjusted ventilatory assist (NAVA) for neonates with congenital diaphragmatic hernias: the NAN-C study
Clinical Snapshot
PICO Framework
| P — Population | Post-operative neonates with congenital diaphragmatic hernia (CDH), median gestational age 38 weeks, median postnatal age 7 days |
| I — Intervention | Neurally adjusted ventilatory assist (NAVA) ventilation mode for 4 hours |
| C — Comparator | Assist control ventilation (ACV) for 4 hours |
| O — Outcomes | Primary: oxygenation index (OI). Secondary: peak Edi, peak inflation pressure (PIP), mean airway pressure (MAP), expiratory tidal volume |
Bottom Line
This small crossover trial suggests NAVA may improve oxygenation compared to conventional assist-control ventilation in post-operative CDH neonates. The 34% reduction in oxygenation index is clinically meaningful, accompanied by lower airway pressures and tidal volumes. However, the evidence is limited by the very small sample size (n=9), high dropout rate, and short intervention periods. While physiologically promising, larger studies with longer follow-up and comprehensive safety data are needed before routine clinical implementation. The crossover design strengthens internal validity but the generalisability remains uncertain given the highly selected population and strict technical requirements for NAVA implementation.
Key Findings
P Value: p = 0.008 for primary outcome
Effect Size: 34% reduction in oxygenation index with NAVA
Primary Outcome: Oxygenation index significantly lower on NAVA (3.9 ± 1.8) versus ACV (5.9 ± 1.61)
Nnt Or Sensitivity: Not calculable from available data
Confidence Interval: Not reported
Clinical Application
Requires NAVA-capable ventilators and trained neonatal intensive care staff. Technology available in major Australian NICUs Relevant to Australian tertiary paediatric centres. NAVA technology available through major ventilator manufacturers. Would require local protocol development and staff training Post-operative neonates with CDH in tertiary NICUs requiring mechanical ventilation
Abstract
Retrospective studies comparing NAVA to assist control ventilation (ACV) in neonates with congenital diaphragmatic hernia (CDH) have shown that ventilatory mode may improve respiratory parameters. The aim of this study is to determine if infants with CDH studied post-operatively had a lower oxygenation index (OI) on NAVA compared to ACV. This dual-centre randomised cross-over trial compared post-operative NAVA with ACV in infants with CDH. Infants were randomised to receive either NAVA or ACV first in a 1:1 ratio for a 4-h period. At the end of each 4-h period, blood gas analysis was performed and the OI calculated. The inspired oxygen concentration (FiO2), the peak inflation (PIP), and mean airway pressure (MAP) were averaged from the last 5 min on each mode. Eleven infants were randomised. Nine infants completed the trial. with median gestational age of 38 (range 34.6-39.3) weeks and median postnatal age of 7 (range 5-36) days. Eight had left-sided CDH, six had patch repair and two had thoracoscopic repair. The mean OI after 4 h on NAVA was 3.9 ± 1.8 compared to 5.9 ± 1.61 on ACV (p = 0.008). The peak Edi (6.05 ± 4.5 versus 9.86 ± 7.3 µV, p = 0.028), PIP (17 ± 6.3 versus 22 ± 5.3 cmH2O, p = 0.017), and MAP (8.7 ± 2.6 versus 11.1 ± 1.8 cmH2O, p = 0.008), expiratory tidal volume (5.06 ± 0.71 versus 9.86 ± 1.29 ml/kg, p = 0.043) were lower on NAVA versus ACV. Two infants were randomised, but the trial was stopped due to a low Edi signal.Conclusion: NAVA compared to ACV improved oxygenation postoperatively in infants with CDH. On NAVA, infants had lower oxygen indices, peak Edi, expiratory tidal volume and peak and mean airway pressures.
References
- 1.Shetty, S., Jenkinson, A., Poole, G., Dassios, T., Harris, C., Kulkarni, A., Duffy, D., & Greenough, A. (2026). Randomised crossover trial of neurally adjusted ventilatory assist (NAVA) for neonates with congenital diaphragmatic hernias: the NAN-C study. European Journal of Pediatrics. https://doi.org/10.1136/adc.63.7_Spec_No.743
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