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Background <p>We aimed to evaluate the association between initial empirical antibiotic therapy (IEAT) and necrotizing enterocolitis (NEC) in very preterm infants at different early onset sepsis (EOS) risk.</p> Methods <p>This prospective, observational, multi-center study enrolled very low birth weight (VLBW) infants of &lt; 32 weeks' gestation without culture-proven EOS. Infants delivered by cesarean section, without rupture of membranes before delivery, and without maternal chorioamnionitis were categorized as low-risk for EOS. Competing risk Cox regression analysis and cumulative incidence function curves were used to analyse the association between the duration of IEAT (0 days, &lt; 3 days, 3–5 days or &gt; 5 days) and NEC cumulative incidence, and death was considered as a competing risk. Finally, restricted cubic spline (RCS) models were used to further examine the relationship between time-varying antibiotic exposure and the risk of NEC.</p> Results <p>Of the 11678 included infants, 2767 infants were categorized as low risk for EOS. In the whole cohort and the infants with non-low-risk EOS, IEAT &lt; 3 days showed a significantly lower risk of NEC (adjusted sHR 0.36, 95% CI [0.19,0.68]; (adjusted sHR 0.40, 95% CI [0.21, 0.79]) and IEAT for 3–5 days showed a lower risk of NEC (adjusted sHR 0.69, 95% CI [0.52, 0.94]; adjusted sHR 0.72, 95% CI [0.5, 1.03]), compared with those with No-IEAT. In the infants with low-risk EOS, there was no significant association between the duration of IEAT and the incidence of NEC. The RCS analysis showed a positive linear relationship between the duration of IEAT and the risk of NEC in very preterm infants at different EOS risk.</p> Conclusions <p>Competing-risk analysis showed that NEC risk may be inversely associated with short-term IEAT in the whole cohort and the non-low-risk EOS group. Notably, the risk of NEC tended to be higher with prolonged IEAT duration in very preterm infants at different EOS risk. These associational findings are exploratory and warrant further investigation.</p>

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Association between initial empirical antibiotic therapy and necrotizing enterocolitis in very preterm infants at different risk for early-onset sepsis: a multicenter cohort study

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  • 发表日期：

    2026年2月17日

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  • Zhenyu Li,
  • Jie Yang,
  • Xinyue Gu,
  • Yanhong Li,
  • Yinquan Xu,
  • Wenhao Zhou,
  • Yun Cao,
  • Shoo K. Lee,
  • Hui Wu,
  • Chao Chen,
  • Lizhong Du,
  • Xiuyong Chen,
  • Huayan Zhang,
  • Xiuying Tian,
  • Yong Ji,
  • Zhankui Li,
  • Bing Yi,
  • Chuanzhong Yang,
  • Ling Liu,
  • Jianhua Fu,
  • Sannan Wang,
  • Dongmei Chen,
  • Changyi Yang,
  • Xirong Gang,
  • Rui Cheng,
  • Ruobing Shan,
  • Shuping Han,
  • Xinnian Pan,
  • Yiheng Dai,
  • Lili Wang,
  • Gang Qiu,
  • Mingxia Li,
  • Hong Jiang,
  • Wenqing Kang,
  • Yuan Shi,
  • Jiangqin Liu,
  • Qin Zhou,
  • Xing Feng,
  • Jiahua Pan,
  • Long Li,
  • Hongping Xia,
  • Zhenlang Lin,
  • Pingyang Chen,
  • Qin Zhang,
  • Falin Xu,
  • Ling Yang,
  • Xinzhu Lin,
  • Xiaoying Li,
  • Li Ma,
  • Deyi Zhuang,
  • Jianhua Sun,
  • Kun Liang,
  • Yinping Qiu,
  • Xiaoyun Zhong,
  • Jinxing Feng,
  • Liping Chen,
  • Mingyan Hei,
  • Wenbin Dong,
  • Huiwen Huang,
  • Zhaoqing Yin,
  • Li Li,
  • Liyan Zhang,
  • Hongxia Song,
  • Huaiyan Wang,
  • Jimei Wang,
  • Hongying Mi,
  • Dong Li,
  • Linkong Zeng,
  • Hongdan Zhu,
  • Qianshen Zhang,
  • Guofang Ding,
  • Yan Gao,
  • Hongyun Wang,
  • Zhen Wang,
  • Hong Zhen,
  • Xiaolu Ma,
  • Fang Wu

摘要

Background

We aimed to evaluate the association between initial empirical antibiotic therapy (IEAT) and necrotizing enterocolitis (NEC) in very preterm infants at different early onset sepsis (EOS) risk.

Methods

This prospective, observational, multi-center study enrolled very low birth weight (VLBW) infants of < 32 weeks' gestation without culture-proven EOS. Infants delivered by cesarean section, without rupture of membranes before delivery, and without maternal chorioamnionitis were categorized as low-risk for EOS. Competing risk Cox regression analysis and cumulative incidence function curves were used to analyse the association between the duration of IEAT (0 days, < 3 days, 3–5 days or > 5 days) and NEC cumulative incidence, and death was considered as a competing risk. Finally, restricted cubic spline (RCS) models were used to further examine the relationship between time-varying antibiotic exposure and the risk of NEC.

Results

Of the 11678 included infants, 2767 infants were categorized as low risk for EOS. In the whole cohort and the infants with non-low-risk EOS, IEAT < 3 days showed a significantly lower risk of NEC (adjusted sHR 0.36, 95% CI [0.19,0.68]; (adjusted sHR 0.40, 95% CI [0.21, 0.79]) and IEAT for 3–5 days showed a lower risk of NEC (adjusted sHR 0.69, 95% CI [0.52, 0.94]; adjusted sHR 0.72, 95% CI [0.5, 1.03]), compared with those with No-IEAT. In the infants with low-risk EOS, there was no significant association between the duration of IEAT and the incidence of NEC. The RCS analysis showed a positive linear relationship between the duration of IEAT and the risk of NEC in very preterm infants at different EOS risk.

Conclusions

Competing-risk analysis showed that NEC risk may be inversely associated with short-term IEAT in the whole cohort and the non-low-risk EOS group. Notably, the risk of NEC tended to be higher with prolonged IEAT duration in very preterm infants at different EOS risk. These associational findings are exploratory and warrant further investigation.