The Solution – Automated Neonatal Resuscitation

The Gen 7 NextStep™ Volume Controlled Neonatal Resuscitator Click here for the Operation video 

The NextStep™  has been developed, patented internationally and independently tested to address the unmet need for Volume-Controlled, safe Neonatal Resuscitation, throughout changes in lung compliance, as the New-born’s lungs transition to life outside the womb.

The NextStep™ is driven by a micro controller and highly accurate miniature linear servomotor, similar to those used in robotic surgery, providing control to within 10% of Operator pre-set target Volume, throughout changes in lung compliance.

The NextStep™ is automated, easy-to-use with continuously monitored Operator SafeSet™ functions ensuring VoluSafe™ operation

Real time on-screen graphical and numeric displays provide additional Operator feedback including real-time leak alerts

Two peer-reviewed bench studies demonstrate the NextStep’s™ unique ability to Control Volume throughout change in compliance with the potential to mitigate Lung & Brain Injury and life-long Respiratory and Neurological insufficiencies, impacting 2M+ Newborns and the 1M+ Deaths annually associated with birth asphyxia.

1.“Routinely-used ventilation devices for newborn resuscitation can triple intended VT and requires further investigation.” Solevåg AL, Haemmerle E, van Os S, Bach KP, Cheung PY, Schmölzer GM. ‘Comparison of positive pressure ventilation devices in a newborn manikin’ J Maternal Fetal Neonatal Med.

2.”All devices, except the NextStep™ delivered a too high VT, up to sixfold the target 5ml at the 2.0mL/cmH2O compliance.” Anne Lee Solevåg, Enrico Haemmerle, Sylvia van Os, Katinka P. Bach, Po-Yin Cheung, Georg M. Schmölzer. ‘A Novel Prototype Neonatal Resuscitator that Controls Tidal Volume and Ventilation Rate: A Comparative Study of Mask Ventilation in a Newborn Manikin.’ Frontiers in Paediatrics / Neonatology

Below: Graphical of ‘Frontiers in Pediatrics / Neonatology’ comparative study results show leading SIB and T-Piece Neonatal Resuscitators deliver multiple times target volume as lung compliance increases, whilst the NextStep™ (green line) uniquely maintains volume within Operator pre-set 5mL (safe) target.

Reflecting the high interest in mitigating Volutrauma and BPD this study has received over 6,100 views, 74% more than any other Frontiers study – Ever.

3. 2023 Animal Trials at the University of Alberta, Centre for the Studies of Asphyxia and Resuscitation (CSAR) further validated earlier studies, showing excessive Volume delivery by current SIB and T-Piece resuscitators whist the NextStep™ maintained Volume across change in compliance on par with the Fabian HFO Ventilator (Acutronic, Switzerland).

‘Main outcome measures: Targeted tidal volume (VT) delivery of 5mL/kg at two lung compliance: 0.5 and 1.5mL/cmH2O.                         

Results: At 0.5mL/cmH2O compliance, the mean (SD) expired VT with the NextStep™ was 5.1(0.2)mL/kg compared to the Fabian 4.8(0.5)mL/kg, SIB 8.9(3.6)mL/kg, SIB+RFM 4.5(1.8)mL/kg, T-Piece 7.4(4.3)mL/kg, and T-Piece+RFM 6.4(3.1)mL/kg. At 1.5mL/cmH2O compliance, the mean (SD) expired VT with the NextStep™ was 5.2(0.6)mL/kg compared to the Fabian 4.4(0.7)mL/kg, SIB 12.1(5.3)mL/kg, SIB+RFM 9.4(3.9)mL/kg, T-Piece 8.6(1.5)mL/kg, and T-Piece+RFM 6.5 (1.6)mL/kg.

Conclusion: The NextStep™ provides consistent VT during PPV, which is comparable to a mechanical ventilator.

Figure 1b. Comparison of expired tidal volume between SIB with RFM (SIB+RFM), SIB only, T-Piece with RFM (T-Piece+RFM), T-Piece only, NextStep™, and Fabian HFO ventilator at 1.5mL/cmH2O compliance. (SIB=self-inflating bag, RFM=respiratory function monitor)’