Pratesi Simone, Ciarcià Martina, Boni Luca, Ghirardello Stefano, Germini Cristiana, Troiani Stefania, Tulli Eleonora, Natile Miria, Ancora Gina, Barone Giovanni, Vedovato Stefania, Bertuola Federica, Parata Francesca, Mescoli Giovanna, Sandri Fabrizio, Corbetta Roberta, Ventura Luisa, Dognini Giulia, Petrillo Flavia, Valenzano Luigia, Manzari Raffaele, Lavizzari Anna, Mosca Fabio, Corsini Iuri, Poggi Chiara, Dani Carlo
Careggi University Hospital, Department of Neuroscience, Psychology, Drug Research and Child Health, University of Florence, Firenze, Italy.
Clinical Trials Coordinating Center, Clinical Epidemiology Unit, IRCCS Ospedale Policlinico San Martino, Genova, Italy.
JAMA Netw Open. 2024 Dec 2;7(12):e2450476. doi: 10.1001/jamanetworkopen.2024.50476.
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.
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.
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).
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.
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).
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.
Clinicaltrials.gov Identifier: NCT02671305.
在接受复苏的早产新生儿中，与早期断脐相比，延迟60秒断脐与死亡率降低相关。然而，在进行呼吸支持时延长断脐时间的影响尚不清楚。
确定与脐血挤推法相比，在保持胎盘循环完整的情况下对早产新生儿进行复苏并长时间延迟断脐是否能改善预后。
设计、地点和参与者：这项随机临床试验（PCI试验）于2016年4月至2023年2月在8家意大利新生儿重症监护病房进行，纳入了单胎妊娠、孕龄在23周0天至29周6天之间出生的早产新生儿。
将纳入的新生儿随机分配，一组在出生时进行复苏，保持胎盘循环完整180秒，另一组采用脐血挤推法并早期断脐（出生后20秒内）。
主要结局是孕龄36周时死亡、3至4级脑室内出血和支气管肺发育不良的复合终点。预先设定的次要终点是复合主要结局的单个组成部分。进行了意向性分析。
在212对随机分组的母婴中，209对（孕龄中位数[四分位间距]为27[26 - 28]周；出生体重中位数[四分位间距]为900[700 - 1070]g）被纳入意向性分析人群；105对被随机分配到胎盘循环完整组，104对被随机分配到脐血挤推组。胎盘循环完整组105例新生儿中有35例（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，脐血挤推组104例新生儿中有39例（38%）出现该复合结局（比值比为0.83；95%置信区间为0.47 - 1.47；P = 0.53）。
在一项针对孕龄23至29周早产新生儿的随机临床试验中，与脐血挤推法相比，3分钟的胎盘完整复苏并未降低死亡、3至4级脑室内出血或支气管肺发育不良的复合结局。
Clinicaltrials.gov标识符：NCT02671305。
