Department of Pediatrics No. 2, Danylo Halytsky Lviv National Medical University, Lviv, Ukraine.
The Neonatal Intensive Care Unit of the Lviv Regional Clinical Hospital, Lviv, Ukraine.
Am J Perinatol. 2024 Apr;41(6):730-738. doi: 10.1055/a-1782-5860. Epub 2022 Feb 25.
The study aimed to investigate, whether expectant management is noninferior to early patent ductus arteriosus (PDA) treatment with regard to the composite of mortality and/or incidence of bronchopulmonary dysplasia (BPD) in very preterm infants.
A total of 208 very preterm infants of the gestational age <32 weeks, birth weight <1,500 g, chronological age <72 hours, and PDA >1.5 mm were randomized between the treatment or expectant management groups. Both, the intention-to-treat and per-protocol analyses were performed.
A total of 104 (50%) patients received rectal ibuprofen ( = 52) or intravenous acetaminophen ( = 52) within first 72 hours of life. In 104 (50%) infants, expectant management was used. Eight of them (8%) received rescue treatment at the median age of 7 (range: 6-13) days. PDA closure rates by the 10th day of life were 81% ( = 84) in the treatment arm, and 58% ( = 60) in the expectant management arm ( < 0.01). The median age at the time of ductus closure was 5 (range: 5-6) days in the treatment arm and 8 (range: 6-11) days in the expectant management arm ( < 0.01). At the time of discharge, ductus was closed in 83% of treated infants and in 78% of patients who were managed expectantly ( > 0.05). No significant difference between the groups was found for the primary clinical outcomes, BPD/death, or the secondary outcomes at a postmenstrual age of 36 weeks or discharge.
Expectant management is noninferior to early PDA treatment for reducing the incidence of death/BPD. Compared with the expectant management, early pharmacological treatment provides more frequent and faster PDA closure in preterm infants with gestational age <32 weeks, but it neither reduces morbidity nor improves survival rates.
· PDA persistence in very preterm infants is associated with an increased risk of BPD/death.. · PDA treatment accelerates ductus closure, but does not improve survival or reduce severe neonatal morbidity.. · Expectant management is not associated with a higher risk of BPD/death..
本研究旨在探讨期待治疗是否不劣于早期动脉导管未闭（PDA）治疗，对于极早产儿死亡率和/或支气管肺发育不良（BPD）的复合结局。
共纳入胎龄<32 周、出生体重<1500g、生后<72 小时、PDA 直径>1.5mm 的 208 例极早产儿，随机分为治疗组和期待治疗组。分别进行意向治疗和方案分析。
共有 104 例（50%）患儿在生后 72 小时内接受直肠布洛芬（52 例）或静脉用对乙酰氨基酚（52 例）治疗。104 例（50%）患儿接受期待治疗。其中 8 例（8%）在中位年龄 7 天（范围：6-13 天）时接受挽救治疗。治疗组第 10 天 PDA 关闭率为 81%（84 例），期待治疗组为 58%（60 例）（<0.01）。治疗组 PDA 关闭的中位时间为生后 5 天（范围：5-6 天），期待治疗组为 8 天（范围：6-11 天）（<0.01）。出院时，治疗组 83%的患儿和期待治疗组 78%的患儿的 PDA 已关闭（>0.05）。两组主要临床结局（BPD/死亡）或校正胎龄 36 周或出院时的次要结局无显著差异。
期待治疗不劣于早期 PDA 治疗，可降低死亡率/BPD 发生率。与期待治疗相比，极早产儿的早期药物治疗可更频繁、更快地关闭 PDA，但不能降低发病率或提高生存率。
· 极早产儿持续性 PDA 与 BPD/死亡风险增加相关。· PDA 治疗可加速导管关闭，但不能改善生存或降低严重新生儿发病率。· 期待治疗与 BPD/死亡风险增加无关。
