胎盘循环完好的复苏与脐带挤奶相比:随机临床试验

IF 10.5 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL
Simone Pratesi, Martina Ciarcià, Luca Boni, Stefano Ghirardello, Cristiana Germini, Stefania Troiani, Eleonora Tulli, Miria Natile, Gina Ancora, Giovanni Barone, Stefania Vedovato, Federica Bertuola, Francesca Parata, Giovanna Mescoli, Fabrizio Sandri, Roberta Corbetta, Luisa Ventura, Giulia Dognini, Flavia Petrillo, Luigia Valenzano, Raffaele Manzari, Anna Lavizzari, Fabio Mosca, Iuri Corsini, Chiara Poggi, Carlo Dani
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引用次数: 0

摘要

重要性:在接受复苏的早产新生儿中,与早期脐带夹紧相比,延迟脐带夹紧60秒可降低死亡率。然而,在呼吸支持下长时间夹持脐带的效果尚不清楚。目的:探讨与脐带挤奶相比,在保持胎盘循环完整的情况下复苏早产新生儿并在长时间延迟后夹紧脐带是否能改善预后。设计、环境和参与者:该随机临床试验(PCI试验)于2016年4月至2023年2月在意大利8个新生儿重症监护病房进行,纳入了单胎妊娠中出生在妊娠23周0天至29周6天的早产儿。干预措施:纳入的新生儿被随机分配接受胎盘循环完整180秒的出生复苏或脐带挤奶,随后早期脐带夹紧(在20秒内)。主要结局和指标:主要结局为妊娠后36周死亡、3至4级脑室内出血和支气管肺发育不良的复合终点。预先指定的次要终点是复合主要结局的单一组成部分。进行意向治疗分析。结果:在随机选取的212例母新生儿中,209例(中位[IQR]胎龄,27[26-28]周;出生体重中位数[IQR]为900 [700-1070]g),纳入意向治疗人群;105例随机分为胎盘循环完整组,104例随机分为脐带挤奶组。胎盘循环完整组105名新生儿中有35名(33%)出现死亡、3至4级脑室内出血或支气管肺发育不良的复合结局,脐带母乳组104名新生儿中有39名(38%)出现死亡、3至4级脑室内出血或支气管肺发育不良的复合结局(优势比0.83;95% ci, 0.47-1.47;p = .53)。结论及相关性:在一项针对23 ~ 29周胎龄早产儿的随机临床试验中,与脐带母乳相比,完整胎盘复苏3分钟并没有降低死亡、3 ~ 4级脑室内出血或支气管肺发育不良的综合结局。试验注册:Clinicaltrials.gov标识符:NCT02671305。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Resuscitation With Placental Circulation Intact Compared With Cord Milking: A Randomized Clinical Trial.

Importance: Among preterm newborns undergoing resuscitation, delayed cord clamping for 60 seconds is associated with reduced mortality compared with early clamping. However, the effects of longer durations of cord clamping with respiratory support are unknown.

Objective: To determine whether resuscitating preterm newborns while keeping the placental circulation intact and clamping the cord after a long delay would improve outcomes compared with umbilical cord milking.

Design, setting, and participants: This randomized clinical trial (PCI Trial) was conducted at 8 Italian neonatal intensive care units from April 2016 through February 2023 and enrolled preterm newborns born between 23 weeks 0 days and 29 weeks 6 days of gestation from singleton pregnancies.

Interventions: Enrolled newborns were randomly allocated to receive at-birth resuscitation with intact placental circulation for 180 seconds or umbilical cord milking followed by an early cord clamping (within 20 seconds of life).

Main outcomes and measures: The primary outcome was the composite end point of death, grade 3 to 4 intraventricular hemorrhage, and bronchopulmonary dysplasia at 36 weeks of postconception age. Prespecified secondary end points were the single components of the composite primary outcome. An intention-to-treat analysis was conducted.

Results: Of 212 mother-newborn dyads who were randomized, 209 (median [IQR] gestational age, 27 [26-28] weeks; median [IQR] birth weight, 900 [700-1070] g) were enrolled in the intention-to-treat population; 105 were randomized to the placental circulation intact group, and 104 were randomized to the cord milking group. The composite outcome of death, grade 3 to 4 intraventricular hemorrhage, or bronchopulmonary dysplasia occurred in 35 of 105 newborns (33%) in the placental circulation intact group vs 39 of 104 newborns (38%) in the cord milking group (odds ratio, 0.83; 95% CI, 0.47-1.47; P = .53).

Conclusions and relevance: In a randomized clinical trial of preterm newborns at 23 to 29 weeks' gestational age, intact placental resuscitation for 3 minutes did not lower the composite outcome of death, grade 3 to 4 intraventricular hemorrhage, or bronchopulmonary dysplasia compared with umbilical cord milking.

Trial registration: Clinicaltrials.gov Identifier: NCT02671305.

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来源期刊
JAMA Network Open
JAMA Network Open Medicine-General Medicine
CiteScore
16.00
自引率
2.90%
发文量
2126
审稿时长
16 weeks
期刊介绍: JAMA Network Open, a member of the esteemed JAMA Network, stands as an international, peer-reviewed, open-access general medical journal.The publication is dedicated to disseminating research across various health disciplines and countries, encompassing clinical care, innovation in health care, health policy, and global health. JAMA Network Open caters to clinicians, investigators, and policymakers, providing a platform for valuable insights and advancements in the medical field. As part of the JAMA Network, a consortium of peer-reviewed general medical and specialty publications, JAMA Network Open contributes to the collective knowledge and understanding within the medical community.
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