Multi-centre, randomised non-inferiority trial of early treatment versus expectant management of patent ductus arteriosus in preterm infants (the BeNeDuctus trial): statistical analysis plan.
Multi-centre, randomised non-inferiority trial of early treatment versus expectant management of patent ductus arteriosus in preterm infants (the BeNeDuctus trial): statistical analysis plan.
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DOI：
10.1186/s13063-021-05594-x
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发表时间：
2021-09-15
期刊：
影响因子：
2.5
通讯作者：
BeNeDuctus trial study group
中科院分区：
文献类型：
--
作者：
Hundscheid T;Donders R;Onland W;Kooi EMW;Vijlbrief DC;de Vries WB;Nuytemans DHGM;van Overmeire B;Mulder AL;de Boode WP;BeNeDuctus trial study group
关于早产儿动脉导管未闭（PDA）的最佳处理存在争议。持续性PDA与新生儿死亡率和发病率相关，但因果关系尚未得到证实。尽管药物和/或手术治疗在PDA闭合中均有效，但这并未改善新生儿结局。对于大多数早产儿来说，PDA最终会自发闭合，因此PDA治疗可能会增加医源性不良反应的风险。因此，预期管理越来越受到关注，即使在缺乏令人信服的证据来支持这一战略。BeNeDogs试验是一项多中心、随机、非劣效性试验，在欧洲早产儿PDA中评估布洛芬早期药物治疗（出生后24-72小时）与期待治疗的效果。胎龄小于28周的早产儿和超声心动图证实的PDA，其传导直径> 1.5 mm，在父母知情同意后随机分配至布洛芬早期药物治疗或期待管理。主要结局指标是死亡率和/或坏死性小肠结肠炎Bell分期≥ IIa和/或支气管肺发育不良的复合结局，均在月经后36周时确定。次要短期结局是住院期间评估的合并症和不良事件，以及在校正年龄2岁时评估的长期神经发育结局。本统计分析计划侧重于短期结局，在不了解数据的情况下编写和提交。ClinicalTrials.gov NTR5479.于2015年10月19日在荷兰试验注册中心注册，由美国国家医学图书馆Clinicaltrials.gov NCT 02884219（2016年5月注册）和欧洲临床试验数据库EudraCT 2017-001376-28申办。
Controversy exists about the optimal management of a patent ductus arteriosus (PDA) in preterm infants. A persistent PDA is associated with neonatal mortality and morbidity, but causality remains unproven. Although both pharmacological and/or surgical treatment are effective in PDA closure, this has not resulted in an improved neonatal outcome. In most preterm infants, a PDA will eventually close spontaneously, hence PDA treatment potentially increases the risk of iatrogenic adverse effects. Therefore, expectant management is gaining interest, even in the absence of convincing evidence to support this strategy. The BeNeDuctus trial is a multicentre, randomised, non-inferiority trial assessing early pharmacological treatment (24–72 h postnatal age) with ibuprofen versus expectant management of PDA in preterm infants in Europe. Preterm infants with a gestational age of less than 28 weeks and an echocardiographic-confirmed PDA with a transductal diameter of > 1.5 mm are randomly allocated to early pharmacological treatment with ibuprofen or expectant management after parental informed consent. The primary outcome measure is the composite outcome of mortality, and/or necrotizing enterocolitis Bell stage ≥ IIa, and/or bronchopulmonary dysplasia, all established at a postmenstrual age of 36 weeks. Secondary short-term outcomes are comorbidity and adverse events assessed during hospitalization and long-term neurodevelopmental outcome assessed at a corrected age of 2 years. This statistical analysis plan focusses on the short-term outcome and is written and submitted without knowledge of the data. ClinicalTrials.gov NTR5479. Registered on October 19, 2015, with the Dutch Trial Registry, sponsored by the United States National Library of Medicine Clinicaltrials.gov NCT02884219 (registered May 2016) and the European Clinical Trials Database EudraCT 2017-001376-28.
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