PDA-TOLERATE Trial: An Exploratory Randomized Controlled Trial of Treatment of Moderate-to-Large Patent Ductus Arteriosus at 1 Week of Age.
PDA-TOLERATE Trial: An Exploratory Randomized Controlled Trial of Treatment of Moderate-to-Large Patent Ductus Arteriosus at 1 Week of Age.
复制标题
PDA-验证试验：一项探索性随机对照试验，是对1周大的中度至大型专利导管的治疗。
DOI：
10.1016/j.jpeds.2018.09.012
复制
发表时间：
2019-03
期刊：
影响因子：
--
通讯作者：
PDA-TOLERATE (PDA: TO LEave it alone or Respond And Treat Early) Trial Investigators
中科院分区：
文献类型：
--
作者：
Clyman RI;Liebowitz M;Kaempf J;Erdeve O;Bulbul A;Håkansson S;Lindqvist J;Farooqi A;Katheria A;Sauberan J;Singh J;Nelson K;Wickremasinghe A;Dong L;Hassinger DC;Aucott SW;Hayashi M;Heuchan AM;Carey WA;Derrick M;Fernandez E;Sankar M;Leone T;Perez J;Serize A;PDA-TOLERATE (PDA: TO LEave it alone or Respond And Treat Early) Trial Investigators
比较第 1 周结束时对中型至大型动脉导管未闭 (PDA) 的早期常规药物治疗与保守方法，保守方法需要在治疗前预先指定呼吸和血流动力学标准。共有 202 名胎龄 <28 周（平均 25.8 ± 1.1 周）、年龄在 6 至 14 天（平均 8.1 ± 2.2 天）之间接受中至大 PDA 分流的新生儿参加了一项探索性随机对照试验。入组时，49% 的患者接受插管，48% 需要鼻通气或持续气道正压通气。各组之间的主要结果（结扎或出院时 PDA 存在）（早期常规治疗 [ERT]，32%；保守治疗 [CT]，39%）或我们预先指定的坏死性小肠结肠炎（ERT，16%；CT，19%）、支气管肺发育不良 (BPD)（ERT，49%；CT， 53%）、BPD/死亡（ERT，58%；CT，57%）、死亡（ERT，19%；CT，10%）以及每周呼吸支持需求。 ERT 组中符合抢救标准的婴儿较少（ERT，31%；CT，62%）。在二次探索性分析中，接受 ERT 的婴儿对正性肌力支持的需求明显减少（ERT，13%；CT，25%）。然而，在胎龄≥26周的婴儿中，接受ERT的婴儿需要更长的时间才能达到120 mL/kg/天的肠内喂养（中位：ERT，14天[范围，4.5-19天]；CT，6天[范围，3-14天]），并且迟发性非凝固酶阴性葡萄球菌菌血症的发生率显着更高（ERT，24%；CT，6天[范围，3-14天]）。 CT，6%）和死亡（ERT，16%；CT，2%）。对于年龄 <28 周、患有中型至大型 PDA 并在第一周后接受呼吸支持的早产儿，ERT 不会减少 PDA 结扎或出院时 PDA 的存在，也不会改善任何预先指定的次要结局，但会延迟完全喂养，并与妊娠 ≥26 周出生的婴儿晚发败血症和死亡率较高相关。 ClinicalTrials.gov：NCT01958320。
To compare early routine pharmacologic treatment of moderate-to-large patent ductus arteriosus (PDA) at the end of week 1 with a conservative approach that requires prespecified respiratory and hemodynamic criteria before treatment can be given. A total of 202 neonates of <28 weeks of gestation age (mean, 25.8 ± 1.1 weeks) with moderate-to-large PDA shunts were enrolled between age 6 and 14 days (mean, 8.1 ± 2.2 days) into an exploratory randomized controlled trial. At enrollment, 49% of the patients were intubated and 48% required nasal ventilation or continuous positive airway pressure. There were no differences between the groups in either our primary outcome of ligation or presence of a PDA at discharge (early routine treatment [ERT], 32%; conservative treatment [CT], 39%) or any of our prespecified secondary outcomes of necrotizing enterocolitis (ERT, 16%; CT, 19%), bronchopulmonary dysplasia (BPD) (ERT, 49%; CT, 53%), BPD/death (ERT, 58%; CT, 57%), death (ERT,19%; CT, 10%), and weekly need for respiratory support. Fewer infants in the ERT group met the rescue criteria (ERT, 31%; CT, 62%). In secondary exploratory analyses, infants receiving ERT had significantly less need for inotropic support (ERT, 13%; CT, 25%). However, among infants who were ≥26 weeks gestational age, those receiving ERT took significantly longer to achieve enteral feeding of 120 mL/kg/day (median: ERT, 14 days [range, 4.5-19 days]; CT, 6 days [range, 3-14 days]), and had significantly higher incidences of late-onset non-coagulase-negative Staphylococcus bacteremia (ERT, 24%; CT,6%) and death (ERT, 16%; CT, 2%). In preterm infants age <28 weeks with moderate-to-large PDAs who were receiving respiratory support after the first week, ERT did not reduce PDA ligations or the presence of a PDA at discharge and did not improve any of the prespecified secondary outcomes, but delayed full feeding and was associated with higher rates of late-onset sepsis and death in infants born at ≥26 weeks of gestation. ClinicalTrials.gov: NCT01958320.
登录
查看更多内容
DOI：
10.1136/adc.2009.180117
发表时间：
2010-11-01
影响因子：
4.4
作者：
Lemmers, Petra M. A.;Molenschot, Mirella C.;van Bel, Frank
通讯作者：
van Bel, Frank
影响因子：
2.9
作者：
Benitz, W. E.
通讯作者：
Benitz, W. E.
影响因子：
5.1
作者：
CLYMAN, RI;MAURAY, F;ROMAN, C
通讯作者：
ROMAN, C
影响因子：
2
作者：
Aranda, Jacob V.;Clyman, Ronald;Darko, Laszlo
通讯作者：
Darko, Laszlo
影响因子：
8
作者：
Good, WV
通讯作者：
Good, WV