Division of Neonatology, Zekai Tahir Burak Maternity, Education, and Research Hospital, Health Sciences University, Ankara, Turkey.
Department of Pediatric Cardiology, Zekai Tahir Burak Maternity, Education, and Research Hospital, Health Sciences University, Ankara, Turkey.
Eur J Pediatr. 2021 Feb;180(2):433-440. doi: 10.1007/s00431-020-03822-1. Epub 2020 Sep 29.
The aim of this study was to evaluate the effect of paracetamol on patent ductus arteriosus (PDA) closure and clinical outcomes in preterm infants when used as standard intermittent bolus and continuous intravenous (IV) infusion. Preterm neonates with birth weight (BW) ≤ 1500 g and gestational age (GA) ≤ 30 weeks were included in this study. During the study period, IV paracetamol therapy was given to all infants with hemodynamically significant patent ductus arteriosus (hsPDA). The patients were divided into the standard IV intermittent bolus infusion group and the continuous IV infusion group. Standard IV intermittent bolus paracetamol therapy was administered in the form of 15-mg/kg doses as 1-h infusions every 6 h for 5 days, while continuous IV paracetamol infusion therapy was administered as a 60-mg/kg/day dose continuously for 5 days. During the study period, 247 patients were evaluated, of which a total of 137 patients with hsPDA were included. There were no significant differences between the intermittent bolus and continuous infusion groups in terms of mean GA or BW. The continuous paracetamol infusion group had significantly higher rates of PDA-related morbidities, multiple paracetamol courses, and PDA ligation procedure compared with the standard intermittent bolus group.Conclusion: Our results were the first in the literature to compare IV paracetamol infusion regimens for PDA. Our results indicate that standard intermittent bolus infusion is still the most appropriate IV paracetamol regimen for the treatment of PDA.Trial registration: ClinicalTrials.gov Identifier: NCT04469413 What is Known: • Paracetamol has been proposed for the treatment of patent ductus arteriosus in preterm neonates. • There is no consensus on the duration and form of administration of paracetamol in hsPDA, and the information on this issue is insufficient. What is New: • Our study was the first in the literature to compare IV paracetamol infusion regimens for PDA. • Standard intravenous intermittent bolus paracetamol infusion was more effective in pharmacologic PDA closure compared with continuous intravenous paracetamol infusion and was associated with lower rates of PDA-related BPD, NEC, and need for ligation.
这项研究的目的是评估在患有临床显著动脉导管未闭(hsPDA)的早产儿中,使用标准间歇性推注和连续静脉输注(IV)两种方式给予扑热息痛对动脉导管关闭和临床结局的影响。本研究纳入了出生体重(BW)≤1500g 和胎龄(GA)≤30 周的早产儿。在研究期间,所有患有 hsPDA 的婴儿均接受了 IV 扑热息痛治疗。将患者分为标准 IV 间歇性推注输注组和连续 IV 输注组。标准 IV 间歇性推注扑热息痛治疗以 15mg/kg 剂量进行,每 6 小时 1 小时输注,持续 5 天,而连续 IV 扑热息痛输注治疗则以 60mg/kg/天的剂量持续 5 天。在研究期间,共评估了 247 例患者,其中共有 137 例 hsPDA 患者。间歇性推注组和连续输注组的平均 GA 或 BW 无显著差异。与标准间歇推注组相比,连续扑热息痛输注组的 PDA 相关并发症、多次扑热息痛疗程和 PDA 结扎术的发生率明显更高。结论:我们的研究结果是文献中首次比较 IV 扑热息痛输注方案治疗 PDA 的结果。我们的研究结果表明,标准间歇推注仍然是治疗 PDA 最适当的 IV 扑热息痛方案。试验注册:ClinicalTrials.gov 标识符:NCT04469413 已知: • 扑热息痛已被提议用于治疗早产儿动脉导管未闭。 • 对于 hsPDA,尚无关于扑热息痛持续时间和给药方式的共识,而且这方面的信息不足。 新发现: • 我们的研究是文献中首次比较 IV 扑热息痛输注方案治疗 PDA 的结果。 • 与连续 IV 扑热息痛输注相比,标准静脉内间歇性推注扑热息痛输注在药理学上关闭 PDA 更有效,并且与较低的 PDA 相关 BPD、NEC 和结扎需求相关。