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首页> 外文期刊>Archives of disease in childhood. Fetal and neonatal edition >A randomised placebo-controlled trial of early treatment of the patent ductus arteriosus
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A randomised placebo-controlled trial of early treatment of the patent ductus arteriosus

机译：动脉导管未闭早期治疗的随机安慰剂对照试验

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Objective Failure of closure of the patent ductus arteriosus (PDA) may be associated with harm. Early cardiac ultrasound-targeted treatment of a large PDA may result in a reduction in adverse outcomes and need for later PDA closure with no increase in adverse effects. Study design Multicentre, double-blind, placebocontrolled randomised trial. Setting Three neonatal intensive care units in Australia. Patients and interventions Eligible infants born <29 weeks were screened for a large PDA and received indomethacin or placebo before age 12 h. Main outcome Death or abnormal cranial ultrasound. Results The trial ceased enrolment early due to lack of availability of indomethacin. 164 eligible infants were screened before 12 h; of the 92 infants with a large PDA, 44 were randomised to indomethacin and 48 to placebo. There was no difference in the main outcome between groups. Infants receiving early indomethacin had significantly less early pulmonary haemorrhage (PH) (2% vs 21%), a trend towards less periventricular/ intraventricular haemorrhage (PIVH) (4.5% vs 12.5%) and were less likely to receive later open-label treatment for a PDA (20% vs 40%). The 72 non-randomised infants with a small PDA were at low risk of pulmonary haemorrhage and had an 80% spontaneous PDA closure rate. Conclusions Early cardiac ultrasound-targeted treatment of a large PDA is feasible and safe, resulted in a reduction in early pulmonary haemorrhage and later medical treatment but had no effect on the primary outcome of death or abnormal cranial ultrasound.
机译：目的关闭动脉导管未闭（PDA）失败可能与伤害有关。大型PDA的早期以心脏超声检查为目标的治疗可能会导致不良结局的减少，并且需要稍后关闭PDA而不增加不良影响。研究设计多中心，双盲，安慰剂对照的随机试验。在澳大利亚设置三个新生儿重症监护室。患者和干预措施对年龄小于29周的符合条件的婴儿进行筛查，以寻找大型PDA，并在12 h之前接受消炎痛或安慰剂。主要结果死亡或颅内超声异常。结果由于缺乏消炎痛，该试验提前停止了研究。在12 h之前筛查了164名合格婴儿;在92名PDA大的婴儿中，有44名被随机分配给消炎痛，而48名被随机分配给安慰剂。两组之间的主要结局无差异。早期接受吲哚美辛的婴儿早期肺出血（PH）明显较少（2％比21％），脑室周围/脑室内出血（PIVH）减少的趋势（4.5％对12.5％），并且以后接受开放标签治疗的可能性较小PDA（20％vs 40％）。有PDA小的72名非随机婴儿的肺出血风险较低，并且自发性PDA闭合率为80％。结论大型心脏PDA的早期心脏超声治疗是可行和安全的，可减少早期肺出血和后期治疗，但对死亡或颅内超声异常的主要结果没有影响。

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