Abstract
Context: The incidence of early-onset neonatal infection has greatly decreased, but a new diagnostic approach is needed to avoid overdiagnosis and overtreatment. The aim of this study was to assess the potential impact of an algorithm incorporating umbilical-cord-blood procalcitonin (PCT) level on neonatal antibiotics prescription rate as compared with current practice.Material and methods: We conducted a prospective study in three maternity wards in France. All term and preterm neonates with the usual risk factors for neonatal group B Streptococcus infection were eligible for umbilical-cord-blood PCT testing. We compared the proportion of neonates who were exposed early to antibiotics (before 6 days of life) to that of neonates for whom antibiotics prescription would be indicated according to the PCT-based algorithm.Results: Among the 3,080 neonates included, 1 neonate presented with certain infection and 38 neonates with probable infection. The global antibiotics prescription rate was 4.6% [95% confidence interval (CI), 4.1–5]. With the PCT-based algorithm, the potential decrease in prescription rate would be 1.8% (95% CI, 1.3–2.3), corresponding to a 39% (95% CI, 37.3–40.7) relative reduction in antibiotics exposure (p < 0.05).Conclusion: These results suggest that the umbilical-cord-blood PCT-based algorithm could significantly help the clinicians in their antibiotic prescription decision to decrease neonatal antibiotics exposure as compared with current practice. If validated in a larger interventional randomized study, this approach could help clinicians stratify the risk of early-onset neonatal infection and initiate early antibiotics treatment in newborns at high risk of infection while limiting the deleterious effects of useless prescriptions in non-infected newborns.
Highlights
Early-onset neonatal infection (EONI) remains one of the leading causes of neonatal morbidity and mortality [1] because of the immune weakness of newborns [2] and fast evolution of sepsis
Stocker et al reported empiric antibiotics treatment administered for ≥ 72 h to 82% of a cohort of neonates with suspected EONI, but only 18% of cases were classified as probable infections and 1% as proven infections [4]
The global exposure to antibiotics treatment was 142/3,080 (4.6%; 95% confidence intervals (CIs), 4.1–5.0) with a significantly different distribution among the centers, from 3.8% (59/1,556; 95% CI, 2.8–4.7) in Center A to 6.2% (22/357; 95% CI, 3.7–8.7) in Center B (p < 0.05)
Summary
Early-onset neonatal infection (EONI) remains one of the leading causes of neonatal morbidity and mortality [1] because of the immune weakness of newborns [2] and fast evolution of sepsis This pathology is considered a diagnostic and therapeutic emergency. Because of the non-specificity of clinical signs of EONI, pediatricians often empirically start antibiotics treatment in well-newborns with suspected EONI but who present none or only a few clinical symptoms before receiving results of bacteriological culture and inflammatory markers. This situation leads to a considerable number of newborns unnecessarily exposed to antibiotics. Such therapeutic strategies have consequences and are responsible for perturbations in the newborn microbiota with possible long-term consequences such as autoimmune, allergic, or metabolic pathologies [6, 7]; resistant bacteria [8]; nosocomial infection and necrotizing enterocolitis [9]; immune system maturation; mother/newborn separation; and increased cost [6, 10, 11]
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