A new procalcitonin cord-based algorithm in early-onset neonatal infection: for a change of paradigm.

Diagnostic of early-onset neonatal infection (EONI) remains an emergency. Recent studies underline the potential benefit of using Procalcitonin (PCT) in early diagnosis of bacterial infections in neonates. The aim of this study was to evaluate the diagnostic value of an umbilical blood cord PCT based algorithm in newborns suspected of EONI. The diagnostic value of the PCT based algorithm was compared to the French one currently in use by analyzing an 18-months database of newborns suspected of EONI in University Hospital of Nantes from March 2011 to September 2012. Among the 2,408 (40.8 %) newborns suspected of infection during this period, 2,366 were included in the study. The incidence of EONI was 3.4‰ (n = 20). There was no significant difference between the sensibilities of the PCT based algorithm and the current algorithm (90 %, respectively, 95%CI 76.9-100 versus 85.4-100; p = 0.90) and between their specificities (respectively 91.7 % (90.6-92.8) versus 87.4 % (86-88.7); p = 0.25). The antibiotic treatment rate would be significantly reduced with the PCT based algorithm [211 i.e. 8.9 % (7.8-10) versus 314 i.e. 13.3 % (11.9-14.7) in the current algorithm; p < 0.005] and less biological analysis would be performed [301 i.e. 12.7 % (11.4-14) versus 937 i.e. 39.6 % (37.6-41.6); p < 0.005]. Blood cord PCT seems to be a new and efficient marker to guide neonatologists taking care of newborns suspected of EONI. The PCT algorithm seems to be a safe alternative in diagnosis of EONI, allowing detection of EONI significantly as well as the current algorithm, without resulting in a substantially higher number of missed infections. These results have to be confirmed by a multicentric validation study.

[Diagnostic value of a new procalcitonin cord sample-guided algorithm to manage newborns suspected of early-onset infection]. / Prise en charge des nouveau-nés suspects d'infection néonatale précoce : valeur diagnostique d'un algorithme intégrant le dosage de la procalcitonine au cordon.

BACKGROUND: Diagnosis of early neonatal infection remains an emergency. Since clinical symptoms and biological markers are neither sensitive nor specific, many newborns suspected of infection undergo biological analysis and empirical antibiotic treatment while awaiting results. Recent studies underline the benefit of using procalcitonin (PCT) to differentiate inflammatory diseases and viral infections from bacterial infections. Joram shows that it is possible to go beyond the physiological peak of PCT in the first days of life by measuring PCT concentration in cord blood. The aim of this prospective study was to evaluate a new algorithm integrating the value of PCT in blood cord for taking care of newborns who have suspected infection. PATIENTS AND METHOD: The diagnostic value of the new algorithm was compared to the diagnostic value of the algorithm currently in use, by analyzing a 9-month prospective database of 1267 newborns suspected of infection. Infection status was established with the ANAES definition and clinical progression. RESULTS: Each infected newborn (n=8) would have been treated without delay with the current algorithm (based on ANAES guidelines) and this new algorithm. The new algorithm had the same diagnostic value as the current algorithm (P=0.5) with 87.5% sensitivity (95%CI [52-98]) versus 100% (95%CI [87-100]) and 87.4% specificity (95%CI [85-90]) versus 83.8% (95%CI [81-86]). Fewer biological analyses 13.1% (95%CI [11-16]) versus 42.2% (95%CI [39-45]) were performed with the PCT cord-guided algorithm than with the current algorithm (P<0.05), leading to a 64.2% cost reduction. Antibiotics were significantly less used with the new algorithm: 13.1% (95%CI [11-16]) versus 16.7% (95%CI [14-19]). CONCLUSION: PCT in cord blood could become a new and efficient marker to help neonatologists take care of newborns suspected of infection. These results must be confirmed by a larger multicenter prospective study.