New Research Shows Masimo SET's Perfusion Index Potentially Useful In the Diagnosis of the Severity of the Preterm Infant and as an Early Screening Tool for Infants Born With Antenatal Infection

:New Research Shows Masimo SET's Perfusion Index Potentially Useful In the Diagnosis of the Severity of the Preterm Infant and as an Early Screening Tool for Infants Born With Antenatal Infection

SNOWBIRD, Utah -- In a presentation at the 20th annual High Frequency Ventilation meeting in Snowbird, Utah, Dr. Claudio De Felice discussed his latest research concerning Masimo SET's Perfusion Index (PI) in the diagnosis and monitoring of sick infants.

Dr. De Felice and Dr. Giuseppe Latini have been conducting their research in the Neonatal Intensive Care Unit of the Le Scotte Hospital in Siena and the Pediatric Division of the Perrino Hospital in Brindisi, Italy. An initial study published in the European Journal of Pediatrics (1) concluded that Masimo Corporation's Perfusion Index (PI) was an accurate predictor of illness severity in high-risk neonates. De Felice's presentation included new data which demonstrates how PI was also found to be an accurate predictor of a perinatal inflammatory disease, technically referred to as chorioamnionits (CA), which is known to be associated with increased risk for mortality and/or long term brain damage.

"The use of Masimo SET Perfusion Index as a diagnostic tool appears to be a breakthrough in caring for high risk newborns," stated De Felice. "Pulse oximetry has been an important tool in caring for newborns for the last 20 years, but we are just now starting to realize the increased usefulness of this parameter with the recent advancements made by Masimo."

In a prospective study, 45 term newborns with histologically documented chorioamnionitis (CA), infection before birth, were compared to a control group of 45 term newborns without CA. A large fraction of CA remains subclinical, with no recognizable predictive clinical signs at birth being known to date. For both groups, Perfusion Index was assessed with the Masimo SET Radical immediately after birth for measurements at 1 minute and 5 minutes. The PI measurements and standard Apgar scores at the 1 minute and 5 minutes time markers were compared between the two groups. The PI at the 1 minute and 5 minutes time marker were statistically different between the groups (p value < 0.0001). In addition, there was statistical difference between the groups for the 1-min Apgar score (p value < 0.0001). On the other hand, birth weight, 5 min Apgar score, 1-min and 5-min SpO2, 1-min and 5-min pulse rate, 1-min and 5-min skin temperature, as well as 1-min and 5-min core temperature were not significantly different between the two groups.

The data from this study suggests the use of Masimo SET Perfusion Index in monitoring of infants in the delivery room for the early screening of neonatal infections. De Felice stated, "The capability of reading Perfusion Index at low perfusion is now made possible by the accuracy and reliability of the Masimo SET Radical. In the past, our conventional pulse oximeters were not reliable or recommended for use in infants during low perfusion. It is important to note that an early CA /antenatal infection diagnosis by measuring low PI may make it possible to improve the outcome of affected neonates. This new capability of working in difficult and very extreme situations (high risk deliveries) and giving us reliable oxygen saturation, pulse rate and PI data has aided us in our clinical practice and is expected to lead to better neonatal outcomes."

Masimo Corporation, founded in 1989, is the innovator and leader of motion and low perfusion tolerant pulse oximetry. Masimo develops, licenses and markets advanced medical signal processing technologies and products for the non-invasive monitoring of vital signs. Masimo Signal Extraction Technology represents a fundamental departure from conventional pulse oximetry technologies. More than 50 independent and objective, published studies have demonstrated that Masimo Signal Extraction Technology substantially overcomes the limitations of conventional pulse oximeters in accurately measuring arterial blood oxygen saturation levels and pulse rates in the presence of patient movement and low perfusion.

(1) De Felice et al. The pulse oximeter perfusion index as a predictor

for high illness severity in neonates.

Eur J Pediatr 2002 ; 161 :561-562.

Source: Masimo Corporation