The NICU Antibiotics and Outcomes (NANO) trial: a randomized multicenter clinical trial assessing empiric antibiotics and clinical outcomes in newborn preterm infants.
The NICU Antibiotics and Outcomes (NANO) trial: a randomized multicenter clinical trial assessing empiric antibiotics and clinical outcomes in newborn preterm infants.
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DOI：
10.1186/s13063-022-06352-3
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发表时间：
2022-05-23
期刊：
影响因子：
2.5
通讯作者：
Yabes, Johathan G.
中科院分区：
文献类型：
--
作者：
Morowitz, Michael J.;Katheria, Anup C.;Polin, Richard A.;Pace, Elizabeth;Huang, David T.;Chang, Chung-Chou H.;Yabes, Johathan G.
关键词：
早发性脓毒症是早产儿人群新生儿发病和死亡的重要原因。尽管极低出生体重 (ELBW) 婴儿中早发性败血症的总体发病率为 2-3%，但被认为早发性败血症风险增加的婴儿在等待血培养确认期间通常会使用广谱抗生素进行经验性治疗。最近的观察性研究将围产期抗生素的使用与 ELBW 婴儿坏死性小肠结肠炎、迟发性败血症和死亡率增加的发生率联系起来。鉴于目前可用的数据和临床实践的可变性，我们设计了一项前瞻性多机构随机对照试验，以确定 ELBW 婴儿早期使用抗生素的安全性。 NICU 抗生素和结果 (NANO) 试验是一项多中心、双盲、随机对照试验。 802 名 ELBW 早产儿样本将接受基于网络的分层分组随机化，以在早发性败血症的常规评估期间接受经验性抗生素（EA；氨苄青霉素和庆大霉素）或安慰剂。参与地点将使用现有的机构方案来确定抗生素剂量和持续时间。在参与地点出生、胎龄 29 周或以下的婴儿有资格参加。排除标准包括产妇宫内感染、血流动力学或呼吸不稳定、因产妇适应症而进行剖腹产但未临产或胎膜破裂时间较长，以及事先服用抗生素。主要结局是参与者指数住院期间坏死性小肠结肠炎、迟发性败血症或死亡的复合发生率。将纵向收集母婴样本并评估微生物组组成和多样性的差异。 NANO 试验旨在比较 ELBW 早产儿出生时使用 EA 与安慰剂的不良后果发生率。如果出生时 EA 使临床结果恶化，那么试验结果可能有助于提供者减少 NICU 中抗生素的使用，从而降低 ELBW 婴儿早期使用抗生素相关并发症的发生率。相反，如果我们发现 EA 可以改善结果，那么该试验将验证以前未得到高质量数据支持的长期临床实践。未来的研究将评估分娩后接受经验性抗生素治疗的婴儿的长期临床和微生物结果。试用注册数据：2019 年 6 月 25 日 NCT03997266。在线版本包含可在 10.1186/s13063-022-06352-3 获取的补充材料。
Early-onset sepsis is an important cause of neonatal morbidity and mortality in the preterm population. Infants perceived to be at increased risk for early-onset sepsis are often treated empirically with broad-spectrum antibiotics while awaiting confirmatory blood cultures, despite an overall incidence of early-onset sepsis of 2–3% among extremely-low-birthweight (ELBW) infants. Recent observational studies associate perinatal antibiotic use with an increased incidence of necrotizing enterocolitis, late-onset sepsis, and mortality among ELBW infants. Given currently available data and variability in clinical practice, we designed a prospective multi-institutional randomized controlled trial to determine the safety of early antibiotic use in ELBW infants. The NICU Antibiotics and Outcomes (NANO) trial is a multicenter, double-blinded, randomized controlled trial. A sample of 802 ELBW preterm infants will undergo web-based stratified block randomization to receive empiric antibiotics (EA; ampicillin and gentamicin) or placebo during routine evaluation for early-onset sepsis. Participating sites will use preexisting institutional protocols for antibiotic dosage and duration. Infants born at participating sites with a gestational age of 29 weeks or less are eligible for enrollment. Exclusion criteria include maternal intrauterine infection, hemodynamic or respiratory instability, delivery by caesarean section for maternal indications without labor or prolonged rupture of membranes, and prior administration of antibiotics. The primary outcome is the composite incidence of necrotizing enterocolitis, late-onset sepsis, or death during participants’ index hospitalization. Maternal and infant samples will be collected longitudinally and assessed for differences in microbiome composition and diversity. The NANO trial is designed to compare the rate of adverse outcomes of EA use at birth versus placebo in ELBW preterm infants. If EA at birth worsens clinical outcomes, then the results of the trial may help providers decrease antibiotic utilization in the NICU and subsequently decrease the incidence of complications associated with early antibiotic use in ELBW infants. If we instead find that EA improve outcomes, then the trial will validate a longstanding clinical practice that has not previously been supported by high-quality data. Future studies will assess long-term clinical and microbial outcomes in infants who received empiric antibiotics following delivery. Trial registration data: June 25, 2019 NCT03997266. The online version contains supplementary material available at 10.1186/s13063-022-06352-3.
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