Isayama Tetsuya, Kusuda Satoshi, Adams Mark, Berti Elettra, Battin Malcolm, Helenius Kjell, Håkansson Stellan, Vento Maximo, Norman Mikael, Reichman Brian, Noguchi Akihiko, Lee Shoo K, Bassler Dirk, Lui Kei, Lehtonen Liisa, Yang Junmin, Shah Prakesh S
Division of Neonatology, Center for Maternal-Fetal Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan.
Neonatal Research Network Japan, Maternal and Perinatal Center, Tokyo Women's Medical University, Tokyo, Japan.
J Pediatr. 2022 May;244:24-29.e7. doi: 10.1016/j.jpeds.2021.12.071. Epub 2022 Jan 4.
To assess whether treating patients with a presymptomatic patent ductus arteriosus (PDA), based on early routine echocardiography, performed regardless of clinical signs, improved outcomes.
This multicenter, survey-linked retrospective cohort study used an institutional-level questionnaire and individual patient-level data and included infants of <29 weeks of gestation born in 2014-2016 and admitted to tertiary neonatal intensive care units (NICUs) of 9 population-based national or regional neonatal networks. Infants in NICUs receiving treatment of presymptomatic PDA identified by routine echocardiography and those not were compared for the primary composite outcome (early death [≤7 days after birth] or severe intraventricular hemorrhage) and secondary outcomes (any in-hospital mortality and major morbidities).
The unit survey (response rates of 86%) revealed a wide variation among networks in the treatment of presymptomatic PDA (7%-86%). Among 246 NICUs with 17 936 infants (mean gestational age of 26 weeks), 126 NICUs (51%) with 7785 infants treated presymptomatic PDA. The primary outcome of early death or severe intraventricular hemorrhage was not significantly different between the NICUs treating presymptomatic PDA and those who did not (17% vs 21%; aOR 1.00, 95% CI 0.85-1.18). The NICUs treating presymptomatic PDA had greater odds of retinopathy of prematurity treatment (13% vs 7%; aOR 1.47, 95% CI 1.01-2.12); however, it was not significant in a sensitivity analysis excluding Japanese data.
Treating presymptomatic PDA detected by routine echocardiography was commonplace but associated with no significant benefits. Well-designed trials are needed to assess the efficacy and safety of early targeted PDA treatment.
评估基于早期常规超声心动图对无症状性动脉导管未闭(PDA)患者进行治疗(无论有无临床体征)是否能改善预后。
这项多中心、与调查相关的回顾性队列研究使用了机构层面的问卷和个体患者层面的数据,纳入了2014 - 2016年出生、孕周小于29周并入住9个基于人群的国家或地区新生儿网络的三级新生儿重症监护病房(NICU)的婴儿。比较接受常规超声心动图检查发现的无症状性PDA治疗的NICU婴儿和未接受治疗的婴儿的主要复合结局(早期死亡[出生后≤7天]或重度脑室内出血)及次要结局(任何住院死亡率和主要并发症)。
单位调查(回复率86%)显示各网络在无症状性PDA治疗方面存在很大差异(7% - 86%)。在拥有17936名婴儿(平均孕周26周)的246个NICU中,126个NICU(51%)的7785名婴儿接受了无症状性PDA治疗。接受无症状性PDA治疗的NICU与未接受治疗的NICU相比,早期死亡或重度脑室内出血的主要结局无显著差异(17%对21%;调整后比值比1.00,95%置信区间0.85 - 1.18)。接受无症状性PDA治疗的NICU发生早产儿视网膜病变治疗的几率更高(13%对7%;调整后比值比1.47,95%置信区间1.01 - 2.12);然而,在排除日本数据的敏感性分析中这一差异并不显著。
通过常规超声心动图检测到的无症状性PDA进行治疗很常见,但未带来显著益处。需要设计良好的试验来评估早期针对性PDA治疗的疗效和安全性。