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The Problem - A 10yr Overview

Ten million newborns worldwide each year need resuscitation assistance. More than one million babies die annually from complications of birth asphyxia.

Respiratory Care 2003;48 (3):288-294 Neonatal Reuscitation Wiswell, Thomas MD

Neonatal chronic lung disease (CLD) is the major long-term pulmonary complication of preterm birth affecting about 20% of infants who need respiratory assistance.

Treatments in Respiratory Medicine. 4(5):347-359, 2005. Sweet, David G 1 2; Halliday, Henry)

Initially, barotrauma was seen as being of major importance... however, increasing evidence has suggested that excessive volume, leading to overexpansion (volutrauma) and inadequate volume, leading to underexpansion/collapse, are more important aetiologically.

Volume-targeted ventilation in the neoanate: time to change?, 2006
A Grover Neonatal Unit, Leicester Royal Infirmary, Leicester, UK, D Field Department of Health Sciences, University of Leicester, Leicester, UK.

“High VT that causes overdistention of the lung plays a key role in ventilator-induced lung injury (VILI). Animal studies have demonstrated that lung injury can occur during resuscitation with just a few large manual inflations. In their classic experiments with mature animals, Dreyfuss et al and Hernandez et al showed that lung injury was caused mainly by high VT ventilation, not by high pressure. Many lesions occurred within 2 minutes of starting ventilation; however, when the VT was controlled so as to avoid lung overdistention, little or no injury occurred.”

Reducing Lung Injury during Neonatal Resuscitation of Preterm Infants. The Journal of Pediatrics 2008 Georg M. Schmölzer, MD, Arjan B. Te Pas, MD, Peter G. Davis, MD, and Colin J. Morley, MD.

“A recent systematic review and meta-analysis shows that volume-targeted ventilation (VTV) compared with pressure-limited ventilation (PLV) reduces death and bronchopulmonary dysplasia, pneumothorax, hypocarbia and severe cranial ultrasound abnormalities.” “As high V T (volutrauma), and not pressure per se, causes lung injury, controlling V T rather than PIP is a logical strategy for ventilating preterm infants.”

A Practical Guide to Neonatal Volume Guarantee Ventilation Journal of Perinatology : Official Journal of the California Perinatal Association. C Klingenberg, K I Wheeler, P G Davis, C J Morley 2011; 31(9):575-585.

“In conclusion, Volume Guaranteed ventilation in combination with surfactant treatment significantly reduced both duration of mechanical ventilation and early neonatal oxygen related morbidities including bronchopulmonary dysplasia, intraventricular hemorrhage, retinopathy of prematurity, necrotizing enterocolitis in preterm infants with respiratory distress syndrome. This data favors the use of Volume Guaranteed ventilation in respiratory support of premature infants.”

Early neonatal outcomes of volume guaranteed ventilation in preterm infants with respiratory distress syndrome. The Journal of Maternal-Fetal and Neonatal Medicine 2013 Mar; 26(4):396-401. Guven S, Bozdag S, Saner H, Cetinkaya M, Yazar AS, Erguven M.

Shortcomings of Current Neonatal Resuscitators

Manually operated.

Control of Tidal Volume, Airway Pressure and Respiratory Rate is operator-dependant and therefore highly variable, especially in high stress resuscitation situations.

Because they cannot accurately control tidal volume, they cannot control the risk of Volutrauma.

Whereas modern ventilators can deliver Volume Guaranteed ventilation, the most commonly used neonatal resuscitation devices, bag valve masks and T-Piece resuscitators, cannot.

The Next Step™ neonatal resuscitator controls volume, pressure and respiratory rate.

The need for Neonatal Resuscitation is most common amongst premature babies.

“1 in 8 babies are now born prematurely in the US, this has increased by 30% since 1981”

Dani Montague CA State Director, March of Dimes 2012.

The rate of premature births is increasing globally.

“Prematurity causes the deaths of 1/3 of all children in the US”

Dr Elliott Main, Chairman, Dept of OBS. and GYN. California Pacific Medical Center.