Pilot study of a new mathematical algorithm for early detection of late-onset sepsis in very low-birth-weight infants.

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.

A mathematical algorithm for detection of late-onset sepsis in very-low birth weight infants: a preliminary diagnostic test evaluation.

OBJECTIVE: To study the diagnostic ability of RALIS (computerized mathematical algorithm and continuous monitoring device) to detect late onset sepsis among very low birth weight preterm neonates. METHODS: Randomly chosen 24 very low birth weight infants with proven sepsis were compared to 22 infants without sepsis. The clinical parameters were retrospectively collected from the medical records. The ability of RALIS to detect late onset sepsis was calculated. RESULTS: RALIS positively identified 23 of the 24 infants with sepsis (sensitivity 95.8%). It indicated sepsis alert median 2.0 days earlier than clinical suspicion. A false positive alert was indicated in 23% (5/22) infants. The specificity, and positive and negative predictive ability of RALIS were 77.3%. 82.1% and 94.4%, respectively. CONCLUSION: RALIS may aid in the early diagnosis of late onset sepsis in very low birth weight preterm infants.