Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: Exposure to adjunctive azithromycin antibiotic prophylaxis for non-elective cesarean delivery does not increase neonatal morbidity or mortality in term or preterm infants.
UNASSIGNED: https://clinicaltrials.gov, NCT01235546.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: Exposure to adjunctive azithromycin antibiotic prophylaxis for non-elective cesarean delivery does not increase neonatal morbidity or mortality in term or preterm infants.
UNASSIGNED: https://clinicaltrials.gov, NCT01235546.
摘要：
目前尚不清楚非选择性剖宫产时辅助预防阿奇霉素是否会对早产儿的新生儿结局产生不同的影响。这项研究的目的是比较非选择性剖宫产前接受阿奇霉素辅助预防的足月和早产儿的新生儿结局是否不同。
■对一项多中心随机对照试验进行计划的二次分析，该试验招募了单胎妊娠≥24周且接受非选择性剖宫产（分娩期间或胎膜破裂后≥4小时）的妇女。妇女接受了标准的抗生素预防，并随机分为辅助阿奇霉素（500mg）或安慰剂。主要复合结局是新生儿死亡，疑似或确诊的新生儿败血症，和严重的新生儿发病率(NEC，PVL,IVH,BPD）。次要结局包括NICU入院，新生儿再入院,培养阳性感染和耐药生物的流行。在胎龄层（早产[小于37周]与足月[37周或更长时间]）之间比较了阿奇霉素与安慰剂的影响的赔率比（OR）。相互作用测试检查了治疗效果与胎龄的同质性。
■分析包括2,013名婴儿，226名早产（11.2%）和1,787名。平均胎龄为34周和39.5周，分别。在学期和早产地层内，阿奇霉素组和安慰剂组的产妇和分娩特征相似.在早产儿（OR0.82，95％CI0.48-1.41）和足月儿（OR1.06，95％CI0.77-1.46）中，暴露于阿奇霉素与安慰剂组的复合新生儿结局的几率没有差异，胎龄之间没有差异(p=0.42)。对次要结局的分析还显示，胎龄内或胎龄之间的治疗效果没有差异。
■非选择性剖宫产术中使用阿奇霉素辅助抗生素预防不会增加足月或早产儿的新生儿发病率或死亡率。
■https://clinicaltrials.gov,NCT01235546。
■对一项多中心随机对照试验进行计划的二次分析，该试验招募了单胎妊娠≥24周且接受非选择性剖宫产（分娩期间或胎膜破裂后≥4小时）的妇女。妇女接受了标准的抗生素预防，并随机分为辅助阿奇霉素（500mg）或安慰剂。主要复合结局是新生儿死亡，疑似或确诊的新生儿败血症，和严重的新生儿发病率(NEC，PVL,IVH,BPD）。次要结局包括NICU入院，新生儿再入院,培养阳性感染和耐药生物的流行。在胎龄层（早产[小于37周]与足月[37周或更长时间]）之间比较了阿奇霉素与安慰剂的影响的赔率比（OR）。相互作用测试检查了治疗效果与胎龄的同质性。
■分析包括2,013名婴儿，226名早产（11.2%）和1,787名。平均胎龄为34周和39.5周，分别。在学期和早产地层内，阿奇霉素组和安慰剂组的产妇和分娩特征相似.在早产儿（OR0.82，95％CI0.48-1.41）和足月儿（OR1.06，95％CI0.77-1.46）中，暴露于阿奇霉素与安慰剂组的复合新生儿结局的几率没有差异，胎龄之间没有差异(p=0.42)。对次要结局的分析还显示，胎龄内或胎龄之间的治疗效果没有差异。
■非选择性剖宫产术中使用阿奇霉素辅助抗生素预防不会增加足月或早产儿的新生儿发病率或死亡率。
■https://clinicaltrials.gov,NCT01235546。
