El-Naggar Walid, Mitra Souvik, Abeysekera Jayani, Disher Tim, Woolcott Christy, Hatfield Tara, McMillan Douglas, Dorling Jon
Division of Neonatal-Perinatal Medicine, Department of Pediatrics, Dalhousie University, Halifax, Canada.
Division of Neonatal-Perinatal Medicine, Department of Pediatrics, Dalhousie University, Halifax, Canada; Division of Neonatology, Department of Pediatrics, University of British Columbia, Vancouver, Canada.
J Pediatr. 2025 Mar;278:114444. doi: 10.1016/j.jpeds.2024.114444. Epub 2024 Dec 24.
To investigate the feasibility of cut-umbilical cord milking (C-UCM) during stabilization of preterm infants after birth.
This was a pilot randomized controlled trial of initial resuscitation. Infants born to eligible, consenting women presenting in preterm labor at <32 weeks' gestation were randomized to receive either the standard practice of deferred cord clamping (DCC) for 30-60 seconds at birth or C-UCM while supporting breathing and following 30 seconds of DCC. The primary outcome was feasibility in terms of percentage recruitment, intervention compliance, safety, and study completion. Short-term clinical outcomes were collected. Analysis was by intention to treat.
Of the 133 pregnant women approached, 93 consented to participate (70%). Fifty infants delivered <32 weeks' gestation were randomized to either C-UCM (25) or DCC (25). Baseline characteristics of infants were similar. All participants completed the study. One infant in the C-UCM group and 5 infants in the DCC group did not receive the allocated intervention. Median (IQR) time to cord milking was 62 (54, 99) seconds and median (IQR) length of the cut-cord milked was 20 (14, 29) cm. C-UCM was not associated with increased adverse effects compared with DCC.
Milking of the long-cut cord after 30 seconds of DCC while supporting breathing was feasible and not associated with significant adverse effects. A larger randomized controlled trial is required to assess the efficacy and safety of this approach on clinical outcomes. C-UCM may be especially useful in situations when DCC is not feasible.
ClinicalTrials.gov: NCT03852134.
探讨出生后早产儿稳定期断脐挤血(C-UCM)的可行性。
这是一项关于初始复苏的试点随机对照试验。孕周<32周、出现早产迹象且符合条件并同意参与的孕妇所分娩的婴儿被随机分组,一组在出生时接受延迟脐带结扎(DCC)30 - 60秒的标准操作,另一组在辅助呼吸并进行30秒DCC后接受C-UCM。主要结局指标包括招募百分比、干预依从性、安全性和研究完成情况等方面的可行性。收集短期临床结局。采用意向性分析。
在133名接触的孕妇中,93名同意参与(70%)。50名孕周<32周出生的婴儿被随机分为C-UCM组(25名)和DCC组(25名)。两组婴儿的基线特征相似。所有参与者均完成研究。C-UCM组有1名婴儿、DCC组有5名婴儿未接受分配的干预。断脐挤血的中位(IQR)时间为62(54, 99)秒,挤血后的断脐中位(IQR)长度为20(14, 29)厘米。与DCC相比,C-UCM并未增加不良反应。
在辅助呼吸的同时,DCC 30秒后对长断脐进行挤血是可行的,且未出现明显不良反应。需要开展更大规模的随机对照试验来评估该方法对临床结局的有效性和安全性。在DCC不可行的情况下,C-UCM可能特别有用。
ClinicalTrials.gov:NCT03852134。