BACKGROUND Neonatal sepsis is a major determinant of neonatal mortality. There is a scarcity of evidence-based guidelines for the duration of antibiotics in culture-positive sepsis. OBJECTIVES The aim of this study was to compare the efficacy of 10- and 14-day antibiotic therapies in the management of culture-positive neonatal sepsis. METHODS This randomized controlled trial was conducted in the neonatal intensive care unit of a tertiary care center among the neonates suffering from culture-positive sepsis (with signs of clinical remission on day 9 of antibiotic) between January 2023 and May 2023. Newborns with major congenital anomaly, deep-seated infections, multi-organ dysfunction, associated fungal infections/infection by multiple organisms and severe birth asphyxia were excluded. Two hundred and thirty-four newborns were randomized into two groups-study (received 10 days of antibiotics) and control (received 14 days of antibiotics). Treatment failure, hospital stay and adverse effects were compared between the two groups. p < 0.05 was taken as the limit of statistical significance. RESULTS Median [interquartile range (IQR)] birth weight and gestational age of the study population (53.8% boys) were 2.424 kg (IQR: 2.183-2.695) and 37.3 weeks (IQR: 35.5-38.1), respectively. Acinetobacter was the most commonly isolated species (56, 23.9%). The baseline characteristics of both groups were almost similar. Treatment failure was similar in the study and control groups (3.8% vs. 1.7%, p = 0.40), with a shorter hospital stay [median (IQR): 14 (13-16) vs. 18 (17-19) days, p < 0.001]. CONCLUSION Ten-day antibiotic therapy was comparable with 14-day antibiotic therapy in efficacy, with a shorter duration of hospital stay and without any significant increase in adverse effects.

中文翻译：

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培养阳性新生儿败血症的 10 天与 14 天抗生素治疗。

背景技术新生儿败血症是新生儿死亡率的主要决定因素。对于培养阳性脓毒症的抗生素持续时间，缺乏循证指南。目的 本研究的目的是比较 10 天和 14 天抗生素治疗在培养阳性新生儿败血症治疗中的疗效。方法 这项随机对照试验在 2023 年 1 月至 2023 年 5 月期间在三级护理中心的新生儿重症监护病房中进行，受试者为患有培养阳性脓毒症（在抗生素第 9 天出现临床缓解迹象）的新生儿。排除异常、深部感染、多器官功能障碍、相关真菌感染/多种生物体感染和严重出生窒息。234 名新生儿被随机分为两组：研究组（接受 10 天的抗生素治疗）和对照组（接受 14 天的抗生素治疗）。比较两组的治疗失败、住院时间和不良反应。p < 0.05 被视为统计显着性的极限。结果 研究人群（53.8% 男孩）的出生体重中位数和胎龄中位数分别为 2.424 公斤（IQR：2.183-2.695）和 37.3 周（IQR：35.5-38.1）。不动杆菌是最常见的分离菌种（56 个，23.9%）。两组的基线特征几乎相似。研究组和对照组的治疗失败率相似（3.8% vs. 1.7%，p = 0.40），住院时间较短[中位 (IQR)：14 (13-16) vs. 18 (17-19) 天， p < 0.001]。结论 10天抗生素治疗与14天抗生素治疗的疗效相当，住院时间较短，且不良反应没有明显增加。