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延迟脐带夹闭对宫内生长受限新生儿的影响:一项随机对照试验。

Effects of delayed cord clamping in intrauterine growth-restricted neonates: a randomized controlled trial.

机构信息

Department of Neonatology, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, 249203, India.

Department of Pediatrics , Cardiology. Division, All India Institute of Medical Sciences, Rishikesh, India.

出版信息

Eur J Pediatr. 2021 Jun;180(6):1701-1710. doi: 10.1007/s00431-021-03959-7. Epub 2021 Jan 21.

DOI:10.1007/s00431-021-03959-7
PMID:33479800
Abstract

The time of cord clamping in intrauterine growth-restricted (IUGR) neonates remains an area of uncertainty. This assessor-blinded randomized controlled trial compared the effects of delayed cord clamping (DCC) with early cord clamping (ECC) on the systemic blood flow (SBF) and cerebral hemodynamics in IUGR neonates of gestational age ≥28 weeks, not requiring resuscitation. Eligible newborns were randomized to DCC (cord clamping after 60 s; n=55) or ECC (cord clamping within 30 s; n=55) group immediately after delivery. The primary outcome variable was superior vena cava (SVC) blood flow at 24±2 h. The secondary outcome variables were right ventricular output (RVO), anterior cerebral artery (ACA) blood flow velocity (BFV), superior mesenteric artery (SMA)-BFV and venous hematocrit at 24±2 h, peak total serum bilirubin (TSB), incidences of polycythemia, intraventricular hemorrhage, respiratory distress, feeding intolerance, and necrotizing enterocolitis, outcome, duration of hospital stay, screening audiometry, and serum ferritin levels at the postnatal age of 3 months. Compared to ECC, DCC was associated with significantly higher SVC flow (101.22±21.02 and 81.27±19.12 mL/kg/min, in DCC and ECC groups, respectively; p<0.0001), and significantly increased RVO, SMA-BFV, venous hematocrit, and serum ferritin levels. Though peak TSB was significantly higher with DCC, duration of phototherapy was comparable. ACA-BFV, incidence of polycythemia, and other outcomes were comparable between the groups.Conclusions: DCC was a safe and beneficial intervention in IUGR infants with an improved SBF and SMA-BFV and an increased hematocrit and serum ferritin levels without higher incidences of polycythemia and requirement of phototherapy for significant hyperbilirubinemia.Trial registration: Clinical Trials Registry of India (CTRI/2019/05/018904) What is Known: • Delayed cord clamping (DCC) increases superior vena cava (SVC) blood flow in preterm neonates. • DCC increases hematocrit and serum ferritin in intrauterine growth-restricted (IUGR) neonates, but there may be an associated risk of polycythemia and neonatal hyperbilirubinemia. What is New: • DCC increases SVC blood flow, right ventricular output, superior mesenteric artery blood flow velocity, venous hematocrit, and serum ferritin in IUGR neonates. • Incidences of polycythemia and duration of phototherapy for significant neonatal hyperbilirubinemia do not increase with DCC.

摘要

在宫内生长受限(IUGR)新生儿中,脐带夹闭时间仍然存在不确定性。本评估者盲法随机对照试验比较了延迟脐带夹闭(DCC)与早期脐带夹闭(ECC)对胎龄≥28 周、无需复苏的 IUGR 新生儿全身血液流动(SBF)和脑血流动力学的影响。符合条件的新生儿在分娩后立即随机分为 DCC(脐带夹闭 60 秒后;n=55)或 ECC 组(脐带夹闭 30 秒内;n=55)。主要结局变量为上腔静脉(SVC)血流在 24±2 小时。次要结局变量为右心室输出(RVO)、大脑前动脉(ACA)血流速度(BFV)、肠系膜上动脉(SMA)-BFV 和 24±2 小时时静脉血细胞比容、峰值总血清胆红素(TSB)、红细胞增多症、颅内出血、呼吸窘迫、喂养不耐受和坏死性小肠结肠炎的发生率、结局、住院时间、听力筛查和出生后 3 个月时血清铁蛋白水平。与 ECC 相比,DCC 与 SVC 流量显著增加相关(分别为 DCC 和 ECC 组的 101.22±21.02 和 81.27±19.12 mL/kg/min;p<0.0001),并且 RVO、SMA-BFV、静脉血细胞比容和血清铁蛋白水平显著升高。尽管 DCC 的峰值 TSB 明显较高,但光疗时间相似。ACA-BFV、红细胞增多症发生率和其他结局在两组间相似。结论:DCC 是 IUGR 婴儿的一种安全且有益的干预措施,可改善 SBF 和 SMA-BFV,并增加血细胞比容和血清铁蛋白水平,而不会增加红细胞增多症的发生率和对显著高胆红素血症的光疗需求。试验注册:印度临床试验注册处(CTRI/2019/05/018904) 已知: • 延迟脐带夹闭(DCC)可增加早产儿的上腔静脉(SVC)血流量。 • DCC 可增加宫内生长受限(IUGR)新生儿的血细胞比容和血清铁蛋白水平,但可能存在红细胞增多症和新生儿高胆红素血症的相关风险。 新发现: • DCC 可增加 IUGR 新生儿的 SVC 血流量、右心室输出、肠系膜上动脉血流速度、静脉血细胞比容和血清铁蛋白。 • DCC 不会增加红细胞增多症的发生率和显著新生儿高胆红素血症的光疗时间。

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