Executive Summary Checklist

Hypoxia in preterm infants can result in severe morbidity and mortality. Supplemental oxygen administration helps avoid hypoxia but hyperoxia can cause retinopathy of prematurity and increased risk for other conditions. Implementing an optimal oxygen targeting guideline can improve neonatal outcomes. To address suboptimal oxygen targeting:

The Performance Gap

It has been clear for many decades that avoiding hypoxia in neonatal care is associated with increased survival and lower rates of cerebral palsy, other significant neurologic compromise. For this reason, hypoxia should be avoided; this is not to say that hyperoxia should be allowed. Supplemental oxygen in newborn infants has been over-utilized worldwide. This practice has been associated with prolonged hospitalizations, blindness for life due to retinopathy of prematurity (ROP), cancer in childhood, chronic lung disease, developmental disabilities, periventricular leukomalacia, cerebral palsy and other oxidant-stress related adverse effects including DNA damage, endocrine and renal damage, decreased myocardial contractility, alveolar collapse, infection, inflammation and fibrosis \cite{Collins_2001,12769184,17537007,15613575,18458550,18446174}. Most if not all of these complications are as a result of care in the newborn period and cannot be fully eradicated. However, evidence shows eliminating inappropriate oxygen administration and increasing the use of oxygen monitoring can lead to significantly decreased rates of these preventable conditions \cite{24838096,Sola_2015}.
The use of unnecessary oxygen or suboptimal administration of oxygen, and the resulting prolonged hospital stays add significantly to health care costs, not to mention the tremendous emotional costs of preventable chronic conditions. Actively addressing the administration and monitoring of oxygen in newborn infants to prevent both hypoxia and hyperoxia can realize significant improvements in the quality and safety of healthcare as well as cost savings \cite{23268664}.
Hospital practices for oxygen monitoring are variable. Many delivery rooms and neonatal intensive care units worldwide adhere to outdated or otherwise inappropriate protocols. The evidence has shown that excessive oxygen administration during the first few minutes of life is noxious. Yet, in many delivery rooms worldwide, pure oxygen (100% O2) is still administered unnecessarily, FiO2 is not measured, and oxygen saturation (SpO2) levels are not adequately monitored \cite{21091987,Shah_2012,Bizzarro_2013,Chow_2003,Deulofeut_2006,2010}. Therefore, there is an opportunity to prevent many adverse effects through education on appropriate oxygen management, such as the measurement of oxygen titration with a blender and monitoring the infant’s saturation level with pulse oximetry technology that can measure through motion and low perfusion \cite{12563061}.
In a two-phased study of two centers that previously used conventional pulse oximetry, both centers simultaneously changed their neonatal oxygen targeting guideline, and one of the centers switched to Signal Extraction Technology pulse oximetry.14 In the first phase of the study, there was no decrease in retinopathy of prematurity at the center using non-Signal Extraction Technology; but there was a 58% reduction in significant retinopathy of prematurity and a 40% reduction in the need for laser eye treatment at the center using Signal Extraction Technology. In the second phase of the study, the center still using non-Signal Extraction Technology switched to Signal Extraction Technology and it experienced similar results as the center already using Signal Extraction Technology.  In the follow up study, the outcomes of 304 very low birth weight infants whose oxygen targeting was performed with non-Signal Extraction Technology pulse oximetry were compared with 396 post-initiative infants whose oxygen targeting was performed after switching to Signal Extraction Technology pulse oximetry.13 After switching to Signal Extraction Technology, there was a 59% reduction in incidence of severe ROP and a 69% reduction in ROP requiring surgery.
A summary of recent publications on extremely premature infants randomly assigned to a lower target oxygen-saturation intention to treat (85 to 89%) or higher target SpO2 intention to treat (91 to 95%) has shown there was neither increased mortality nor serious brain injuries as a result of avoiding hyperoxia in preterm infants \cite{Stenson_2011,Saugstad_2011,Castillo_2008,Askie_2011}. Also a recent presentation by Askie et al (Cochrane review) shows that there is no difference in the primary outcome of death or disability between the two intentions to treat studied, a higher (91-95%) versus a lower (85-89%) arterial oxygen saturations. Higher rate of NEC occurred with lower intention to treat (85-89%) and a higher rate of severe ROP with higher target range (91-95%). Recently the Committee on Fetus and Newborn of the AAP have made clinical recommendations which are included in this document \cite{Cummings_2016}.
Therefore, an intention to treat with SpO2 of 85-89% should be avoided. There are several issues that suggest extreme caution should be used in the interpretation of these randomized controlled trials \cite{Manja_2015,25357098,24973289}. Additionally, narrow ranges are difficult to maintain for more than 50-60% of the time \cite{Di_Fiore_2014}. To date, the “perfect” SpO2 target range is still not known for all newborns at all times \cite{Saugstad_2010}.
In summary, in extremely low birth weight infants the ideal oxygen saturation range or intention to treat remains unknown and is a compromise among negative outcomes associated with either hyperoxemia (ROP, BPD) or hypoxemia (NEC, death). The appropriate SpO2 range for an individual infant will depend on the type of SpO2 monitor used, gestational age, postnatal age, hemoglobin A concentration, hemoglobin level, oxygen content, cardiac output, clinical diagnosis and illness severity \cite{Castillo_2010}. Despite this variability, it is clear that in order to improve clinical outcomes, some clinical practices must be eradicated and replaced with guidelines of clinical care aimed at avoiding both hyperoxia and hypoxia.

Alarms:

Based on these considerations, there is a need to introduce clinical measures at all institutions caring for newborn infants to close the gap between knowledge and practice. The lack of a systematic approach to prevent hypoxia and hyperoxia significantly affects patient safety, quality, and cost of care. Closing the performance gap will require hospitals, healthcare systems and all members of the neonatal health care team (RN’s, RT’s and MD’s) to commit to action in the form of specific leadership, practice, and technology plans to improve safety for newborn infants who require oxygen supplementation.

Leadership Plan