Abstract
Background Diagnosis of late onset sepsis (LOS) in very low birth weight (VLBW) preterm infants
relies mainly on clinical suspicion, whereas prognosis depends on early initiation
of antibiotic treatment. RALIS is a mathematical algorithm for early detection of
LOS incorporating six vital signs measured every 2 hours.
Objective The aim of this study is to study RALIS ability to detect LOS before clinical suspicion.
Study Design A total of 118 VLBW preterm infants (gestational age < 33 weeks, birth weight < 1,500
g) were enrolled in a prospective multicentered study. Vital signs were recorded prospectively
up to day 21 of life in a blinded manner, with no effect on standard care. The primary
end point was comparison of the rates and timing of detection of LOS between RALIS
and clinical/culture evidence of LOS.
Results Of the 2,174 monitoring days, RALIS indicated sepsis in 590 days, and LOS was positively
diagnosed in 229 days. Sensitivity, specificity, positive, and negative predictive
values were 74.6, 80.7, 38.8, and 95.1%, respectively. RALIS provided an indication
for sepsis 3 days on the average before clinical suspicion.
Conclusion RALIS has a promising potential as an easy to implement noninvasive early indicator
of LOS, especially for ruling out LOS in VLBW high-risk infants.
Keywords
sepsis - premature infant - very low-birth-weight infant - morbidity - mortality
