Serum calprotectin as a marker of neonatal sepsis: a hospital-based cross-sectional diagnostic study

Abstract

Background: Despite significant advances in neonatal care, neonatal sepsis remains a major contributor to mortality, morbidity, and protracted hospitalization. The development of early possible diagnostic indicators for newborn sepsis is critical. Since calprotectin participates in major biological processes, it could be a diagnostic marker for infection/inflammation. This study aimed to estimate serum calprotectin in neonates with clinical sepsis. In addition, we compared serum calprotectin with standard sepsis markers and serum procalcitonin to evaluate its diagnostic accuracy. Methods: A hospital-based cross-sectional diagnostic study of neonates identified with clinical sepsis using standard criteria was carried out. We compared estimated serum calprotectin levels to serum procalcitonin levels and conventional sepsis markers (leucocyte count, blood culture, immature to total neutrophil ratio, and C- reactive protein). We used SPSS version 25 to analyze the data. To examine diagnostic accuracy and determine a cut-off value for serum calprotectin, we used the receiver operating characteristics (ROC) curve. Results: Of the 83 subjects included, 36.5% (30/83) had blood culture positive status, the median value of serum calprotectin being 0.93 ng/ml (0.67 to 1.3). Respiratory, cardiovascular, and gastrointestinal instabilities were present in 67.5% (56/83), 59% (49/83), and 50.1% (42/83) cases, respectively. The presence of positive and negative blood cultures did not significantly affect sepsis parameters (p=0.09). On ROC, calprotectin was not predictive for blood culture positivity (sensitivity: 50%; specificity: 44% at 0.83 ng/ml of serum calprotectin) and C-reactive protein (CRP) levels (sensitivity: 57%; specificity: 67% at serum calprotectin levels of 0.89 ng/ml). However, compared with serum procalcitonin, serum calprotectin at 1.2 ng/ml had sensitivity and specificity of 60% and 73%, respectively. Conclusions: Serum calprotectin did not show a distinct advantage over the existing sepsis markers. Serum calprotectin level at 1.2 ng/ml had a sensitivity and specificity of 60% and 73%, respectively, compared to serum procalcitonin in detecting neonatal sepsis.

Serum calprotectin as a marker of neonatal sepsis: a hospital-based cross-sectional diagnostic study

“…The median values of CRP, TLC, serum calprotectin, and serum procalcitonin are presented in Table 1. 22 Among the clinical criteria for suspecting clinical sepsis in neonates (Figure 2), respiratory instability was present in 68% (56/83), cardiovascular and gastrointestinal instability in 59% (49/83) and 51% (42/83) cases, respectively. While Increased oxygen requirement, tachypnea, and apnea were found in 41% (34/83), 36.1% (30/83), and 16.8% (14/83) cases, respectively.…”

“…The reporting guidelines contain a completed STARD checklist. 22 Figure 1 depicts the study flow according to STARD criteria. 22…”

“…We gave the parents a participant information sheet with answers to the most frequently asked queries (as in Extended data). 22 We obtained signed informed consent (as in Extended data) 22 if the parents or guardians were willing for their newborns to participate. We gathered the baseline demographic information and neonatal medical history using a validated semi-structured pretested proforma (as in Extended data).…”

“…We gathered the baseline demographic information and neonatal medical history using a validated semi-structured pretested proforma (as in Extended data). 22 Inclusion and exclusion criteria Admitted neonates with clinical sepsis diagnosed as per the clinical criteria were included. We excluded ventilated neonates with respiratory or circulatory failure, previous exposure to antibiotics, preterm less than 32 weeks, had APGAR scores less than "3" or had conditions such as persistent pulmonary hypertension of newborn, congenital malformations, surgical-related disorders including necrotizing enterocolitis (NEC), and severe intracranial bleeding.…”

“…https://doi.org/10.17605/OSF.IO/6V84E. 22 This dataset contains the following underlying extended data:…”