Procalcitonin for the diagnosis of sepsis in neonates: a diagnostic test accuracy review

Objectives This is a protocol for a Cochrane Review (diagnostic). The objectives are as follows: To evaluate the diagnostic accuracy of procalcitonin in culture proven early‐ or late‐onset neonatal sepsis. Secondary objectives To evaluate the diagnostic accuracy of procalcitonin in all sepsis (including both culture‐proven and culture‐negative early‐ or late‐onset neonatal sepsis). To evaluate the diagnostic accuracy of procalcitonin in all sepsis at the most common threshold ranges used (0.5 to 1 ng/mL and ≥ 2 ng/mL). We plan to investigate heterogeneity with respect to the following covariates if adequate data are available. Timing of sepsis onset: a) EOS (≤ 72 hours), b) LOS (> 72 hours). Maturity of infant: a) term (≥ 37 week gestation) b) preterm gestation (< 37 weeks gestation). Pathogen type: a) bacterial b) fungal. Nature of threshold determination: a) threshold identified a priori b) post‐hoc ascertainment of threshold.