The Solution – Automated Neonatal Resuscitation

The Gen 6 NextStep Volume Controlled Neonatal Resuscitator Click here for 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 whilst immediately alerting of any leak.

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. https://www.tandfonline.com/doi/abs/10.1080/14767058.2016.1180360?journalCode=ijmf20

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 https://www.frontiersin.org/articles/10.3389/fped.2016.00129/full

3. Animal trials are planned for 2022 which, subject to the laws of Physics remaining constant, will further validate the NextStep™ Volume Control technology.

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 5,300 views, 73% more than any other Frontiers study. Ever.

http://loop-impact.frontiersin.org/impact/article/226151#totalviews/views