OBJECTIVES To determine whether rate of severe intraventricular hemorrhage (IVH) or death among preterm infants receiving placental transfusion with UCM is noninferior to delayed cord clamping (DCC). METHODS Noninferiority randomized controlled trial comparing UCM versus DCC in preterm infants born 28 to 32 weeks recruited between June 2017 through September 2022 from 19 university and private medical centers in 4 countries. The primary outcome was Grade III/IV IVH or death evaluated at a 1% noninferiority margin. RESULTS Among 1019 infants (UCM n = 511 and DCC n = 508), all completed the trial from birth through initial hospitalization (mean gestational age 31 weeks, 44% female). For the primary outcome, 7 of 511 (1.4%) infants randomized to UCM developed severe IVH or died compared to 7 of 508 (1.4%) infants randomized to DCC (rate difference 0.01%, 95% confidence interval: (-1.4% to 1.4%), P = .99). CONCLUSIONS In this randomized controlled trial of UCM versus DCC among preterm infants born between 28 and 32 weeks' gestation, there was no difference in the rates of severe IVH or death. UCM may be a safe alternative to DCC in premature infants born at 28 to 32 weeks who require resuscitation.

中文翻译：

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28 至 32 周婴儿脐带挤奶与延迟脐带结扎：一项随机试验。


目的 确定接受 UCM 胎盘输注的早产儿严重脑室内出血 (IVH) 或死亡的发生率是否不劣于延迟脐带结扎 (DCC)。方法 非劣效性随机对照试验，对 2017 年 6 月至 2022 年 9 月期间从 4 个国家的 19 所大学和私立医疗中心招募的 28 至 32 周出生的早产儿进行 UCM 与 DCC 比较。主要结局是 III/IV 级 IVH 或按 1% 非劣效性界限评估的死亡。结果 在 1019 名婴儿（UCM n = 511 和 DCC n = 508）中，所有婴儿从出生到初次住院都完成了试验（平均胎龄 31 周，44% 为女性）。对于主要结局，随机分配至 UCM 的 511 名婴儿中有 7 名 (1.4%) 出现严重 IVH 或死亡，而随机分配至 DCC 的 508 名婴儿中有 7 名 (1.4%)（比率差异 0.01%，95% 置信区间：（-1.4% 到1.4%），P = .99）。结论 在这项对妊娠 28 至 32 周之间出生的早产儿进行 UCM 与 DCC 的随机对照试验中，严重 IVH 或死亡的发生率没有差异。对于 28 至 32 周出生且需要复苏的早产儿，UCM 可能是 DCC 的安全替代方案。