Division of Neonatology and Neonatal Intensive Care Unit, Department of Maternal and Child Health, Santa Chiara Hospital, University of Pisa, Pisa, Italy.
Centro di Formazione e Simulazione Neonatale "NINA", Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
Ital J Pediatr. 2021 Mar 25;47(1):73. doi: 10.1186/s13052-021-01028-1.
According to most early-onset sepsis (EOS) management guidelines, approximately 10% of the total neonatal population are exposed to antibiotics in the first postnatal days with subsequent increase of neonatal and pediatric comorbidities. A review of literature demonstrates the effectiveness of EOS calculator in reducing antibiotic overtreatment and NICU admission among neonates ≥34 weeks' gestational age (GA); however, some missed cases of culture-positive EOS have also been described.
Single-center retrospective study from 1st January 2018 to 31st December 2018 conducted in the Division of Neonatology at Santa Chiara Hospital (Pisa, Italy). Neonates ≥34 weeks' GA with birth weight ≤ 1500 g, 34-36 weeks' GA neonates with suspected intraamniotic infection and neonates ≥34 weeks' GA with three clinical signs of EOS or two signs and one risk factor for EOS receive empirical antibiotics. Neonates ≥34 weeks' GA with risk factors for EOS or with one clinical indicator of EOS undergo serial measurements of C-reactive protein and procalcitonin in the first 48-72 h of life; they receive empirical antibiotics in case of abnormalities at blood exams with one or more clinical signs of EOS. Two hundred sixty-five patients at risk for EOS met inclusion criteria; they were divided into 3 study groups: 34-36 weeks' GA newborns (n = 95, group A), ≥ 37 weeks' GA newborns (n = 170, group B), and ≥ 34 weeks' GA newborns (n = 265, group A + B). For each group, we compared the number of patients for which antibiotics would have been needed, based on EOS calculator, and the number of the same patients we treated with antibiotics during the study period. Comparisons between the groups were performed using McNemar's test and statistical significance was set at p < 0.05; post-hoc power analysis was carried out to evaluate the sample sizes.
32/265 (12.1%) neonates ≥34 weeks' GA received antibiotics within the first 12 h of life. According to EOS calculator 55/265 (20.7%) patients would have received antibiotics with EOS incidence 2/1000 live births (p < 0.0001).
Our evidence-based protocol entails a further decrease of antibiotic overtreatment compared to EOS calculator. No negative consequences for patients were observed.
根据大多数早发性败血症 (EOS) 管理指南，约有 10%的新生儿在出生后的头几天内接触抗生素，随后新生儿和儿科合并症的发病率会增加。文献综述表明，EOS 计算器可有效减少≥34 周胎龄 (GA) 新生儿的抗生素过度治疗和新生儿重症监护病房 (NICU) 入院率；然而，也有一些培养阳性 EOS 漏诊的病例。
这是一项于 2018 年 1 月 1 日至 12 月 31 日在意大利比萨圣基亚拉医院新生儿科进行的单中心回顾性研究。纳入胎龄≥34 周、出生体重≤1500g 的新生儿，胎龄 34-36 周、疑似宫内感染的新生儿，以及胎龄≥34 周、出现 EOS 三联征或二联征加一个 EOS 危险因素的新生儿，给予经验性抗生素治疗。胎龄≥34 周、有 EOS 危险因素或有一个 EOS 临床指标的新生儿，在出生后 48-72 小时内进行 C 反应蛋白和降钙素原的连续测量；如果血液检查出现异常，且出现一个或多个 EOS 临床体征，给予经验性抗生素治疗。有 265 例 EOS 高危患儿符合纳入标准，分为 3 个研究组：胎龄 34-36 周新生儿 (n=95，A 组)、胎龄≥37 周新生儿 (n=170，B 组)、胎龄≥34 周新生儿 (n=265，A+B 组)。对于每个组，我们比较了根据 EOS 计算器需要使用抗生素的患者数量，以及在研究期间我们用抗生素治疗的同一患者数量。使用 McNemar 检验进行组间比较，设定统计学显著性水平为 p<0.05；进行事后功效分析以评估样本量。
265 例胎龄≥34 周的新生儿中，有 32 例 (12.1%)在出生后 12 小时内接受了抗生素治疗。根据 EOS 计算器，55/265(20.7%)患者需要使用抗生素，EOS 发病率为 2/1000 活产儿 (p<0.0001)。
我们的循证方案与 EOS 计算器相比，进一步减少了抗生素的过度治疗。未观察到对患者产生任何负面影响。
