Neonatal outcomes in term and preterm infants following adjunctive azithromycin antibiotic prophylaxis for non-elective cesarean delivery.

IF 16.4 1区 化学 Q1 CHEMISTRY, MULTIDISCIPLINARY
Accounts of Chemical Research Pub Date : 2024-12-01 Epub Date: 2024-06-14 DOI:10.1080/14767058.2024.2367082
Jane K Martin, Sherri A Longo, Victoria R Jauk, Erin A S Clark, George R Saade, Kim A Boggess, Sean Esplin, Ronald J Wapner, Michelle Y Owens, Sean C Blackwell, William W Andrews, Jeff M Szychowski, Alan T Tita
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引用次数: 0

Abstract

Objective: It is currently unknown whether adjunctive azithromycin prophylaxis at the time of non-elective cesarean has differential effects on neonatal outcomes in the context of prematurity. The objective of this study was to compare whether neonatal outcomes differ in term and preterm infants exposed to adjunctive azithromycin prophylaxis before non-elective cesarean delivery.

Study design: A planned secondary analysis of a multi-center randomized controlled trial that enrolled women with singleton pregnancies ≥24 weeks gestation undergoing non-elective cesarean delivery (during labor or ≥4 h after membrane rupture). Women received standard antibiotic prophylaxis and were randomized to either adjunctive azithromycin (500 mg) or placebo. The primary composite outcome was neonatal death, suspected or confirmed neonatal sepsis, and serious neonatal morbidities (NEC, PVL, IVH, BPD). Secondary outcomes included NICU admission, neonatal readmission, culture positive infections and prevalence of resistant organisms. Odds ratios (OR) for the effect of azithromycin versus placebo were compared between gestational age strata (preterm [less than 37 weeks] versus term [37 weeks or greater]). Tests of interaction examined homogeneity of treatment effect with gestational age.

Results: The analysis includes 2,013 infants, 226 preterm (11.2%) and 1,787 term. Mean gestational ages were 34 and 39.5 weeks, respectively. Within term and preterm strata, maternal and delivery characteristics were similar between the azithromycin and placebo groups. There was no difference in the odds of composite neonatal outcome between those exposed to azithromycin versus placebo in preterm neonates (OR 0.82, 95% CI 0.48-1.41) and in term neonates (OR 1.06, 95% CI 0.77-1.46), with no difference between gestational age strata (p = 0.42). Analysis of secondary outcomes also revealed no differences in treatment effects within or between gestational age strata.

Conclusion: Exposure to adjunctive azithromycin antibiotic prophylaxis for non-elective cesarean delivery does not increase neonatal morbidity or mortality in term or preterm infants.

Clinical trial registration: https://clinicaltrials.gov, NCT01235546.

非选择性剖宫产术后辅助使用阿奇霉素抗生素预防的足月儿和早产儿的新生儿预后。
目的:目前尚不清楚在非选择性剖宫产时辅助使用阿奇霉素是否会对早产儿的新生儿预后产生不同影响。本研究旨在比较在非选择性剖宫产前接受阿奇霉素辅助预防的足月儿和早产儿的新生儿预后是否存在差异:研究设计:一项多中心随机对照试验的计划二次分析,该试验招募了妊娠≥24周、接受非选择性剖宫产(分娩过程中或胎膜破裂后≥4小时)的单胎妊娠妇女。产妇接受标准抗生素预防,并随机接受阿奇霉素(500 毫克)或安慰剂辅助治疗。主要综合结果为新生儿死亡、疑似或确诊新生儿败血症、新生儿严重发病(NEC、PVL、IVH、BPD)。次要结果包括新生儿重症监护室入院率、新生儿再入院率、培养阳性感染率和耐药菌感染率。在不同胎龄层(早产[小于 37 周]与足月[37 周或以上])之间比较了阿奇霉素与安慰剂的效应比(OR)。交互作用测试检验了治疗效果与胎龄的同质性:分析包括 2,013 名婴儿,其中早产儿 226 名(11.2%),足月儿 1,787 名。平均胎龄分别为 34 周和 39.5 周。在足月儿和早产儿组中,阿奇霉素组和安慰剂组的产妇和分娩特征相似。在早产新生儿(OR 0.82,95% CI 0.48-1.41)和足月新生儿(OR 1.06,95% CI 0.77-1.46)中,阿奇霉素组与安慰剂组的新生儿综合结局几率没有差异,胎龄分层之间也没有差异(P = 0.42)。对次要结果的分析也显示,妊娠年龄层内或妊娠年龄层之间的治疗效果没有差异:临床试验注册:https://clinicaltrials.gov,NCT01235546。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Accounts of Chemical Research
Accounts of Chemical Research 化学-化学综合
CiteScore
31.40
自引率
1.10%
发文量
312
审稿时长
2 months
期刊介绍: Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.
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