美国圣地亚哥夏普玛丽伯奇妇幼医院Anup Katheria联合阿拉巴马大学伯明翰分校Gary Cutter研究小组取得一项新突破。他们研究了早产儿脐带挤勒和延迟脐带结扎与死亡或严重脑室内出血的关系。这一研究成果发表在2019年11月19日出版的《美国医学会杂志》上。

脐带挤勒作为延迟脐带结扎的替代方法，能为早产儿提供同等的益处，但不会延迟复苏。

2017年6月至2018年9月，研究组对4个国家的9所大学和私人医疗中心的早产儿（孕22-31周分娩）进行了一项非劣效性、随机、临床试验，共招募了474名早产婴儿，将其随机分组，236例接受脐带挤勒，238例接受延迟脐带结扎。

脐带挤勒组中有29例（12%）婴儿死亡或发展为严重脑室内出血，延迟脐带结扎组中有20例（8%），差异不显著。脐带挤勒组中有20例（8%）婴儿发生严重脑室内出血，显著高于延迟脐带结扎组（8例，3%）。

妊娠周数与治疗组的交互作用试验仅对严重脑室内出血有显著意义，其中在孕23-27周分娩的婴儿中，脐带挤勒组严重脑室内出血的发生率为22%，显著高于延迟脐带结扎组（6%）。

总之，在不足32周的早产儿中，脐带挤勒与延迟脐带结扎相比，严重脑室内出血的风险显著增加。

附：英文原文

Title: Association of Umbilical Cord Milking vs Delayed Umbilical Cord Clamping With Death or Severe Intraventricular Hemorrhage Among Preterm Infants

Author: Anup Katheria, Frank Reister, Jochen Essers, Marc Mendler, Helmut Hummler, Akila Subramaniam, Waldemar Carlo, Alan Tita, Giang Truong, Shareece Davis-Nelson, Georg Schmlzer, Radha Chari, Joseph Kaempf, Mark Tomlinson, Toby Yanowitz, Stacy Beck, Hyagriv Simhan, Eugene Dempsey, Keelin O’Donoghue, Shazia Bhat, Matthew Hoffman, Arij Faksh, Kathy Arnell, Wade Rich, Neil Finer, Yvonne Vaucher, Paritosh Khanna, Mariana Meyers, Michael Varner, Phillip Allman, Jeff Szychowski, Gary Cutter

Issue&Volume: 2019/11/19

Abstract:

Importance  Umbilical cord milking as an alternative to delayed umbilical cord clamping may provide equivalent benefits to preterm infants, but without delaying resuscitation.

Objective  To determine whether the rates of death or severe intraventricular hemorrhage differ among preterm infants receiving placental transfusion with umbilical cord milking vs delayed umbilical cord clamping.

Design, Setting, and Participants  Noninferiority randomized clinical trial of preterm infants (born at 23-31 weeks’ gestation) from 9 university and private medical centers in 4 countries were recruited and enrolled between June 2017 and September 2018. Planned enrollment was 750 per group. However, a safety signal comprising an imbalance in the number of severe intraventricular hemorrhage events by study group was observed at the first interim analysis; enrollment was stopped based on recommendations from the data and safety monitoring board. The planned noninferiority analysis could not be conducted and a post hoc comparison was performed instead. Final date of follow-up was December 2018.

Interventions  Participants were randomized to umbilical cord milking (n = 236) or delayed umbilical cord clamping (n = 238).

Main Outcomes and Measures  The primary outcome was a composite of death or severe intraventricular hemorrhage to determine noninferiority of umbilical cord milking with a 1% noninferiority margin.

Results  Among 540 infants randomized, 474 (88%) were enrolled and completed the trial (mean gestational age of 28 weeks; 46% female). Twelve percent (29/236) of the umbilical cord milking group died or developed severe intraventricular hemorrhage compared with 8% (20/238) of the delayed umbilical cord clamping group (risk difference, 4% [95% CI, −2% to 9%]; P = .16). Although there was no statistically significant difference in death, severe intraventricular hemorrhage was statistically significantly higher in the umbilical cord milking group than in the delayed umbilical cord clamping group (8% [20/236] vs 3% [8/238], respectively; risk difference, 5% [95% CI, 1% to 9%]; P = .02). The test for interaction between gestational age strata and treatment group was significant for severe intraventricular hemorrhage only (P = .003); among infants born at 23 to 27 weeks’ gestation, severe intraventricular hemorrhage was statistically significantly higher with umbilical cord milking than with delayed umbilical cord clamping (22% [20/93] vs 6% [5/89], respectively; risk difference, 16% [95% CI, 6% to 26%]; P = .002).

Conclusions and Relevance  In this post hoc analysis of a prematurely terminated randomized clinical trial of umbilical cord milking vs delayed umbilical cord clamping among preterm infants born at less than 32 weeks’ gestation, there was no statistically significant difference in the rate of a composite outcome of death or severe intraventricular hemorrhage, but there was a statistically significantly higher rate of severe intraventricular hemorrhage in the umbilical cord milking group. The early study termination and resulting post hoc nature of the analyses preclude definitive conclusions.

DOI: 10.1001/jama.2019.16004

Source: https://jamanetwork.com/journals/jama/article-abstract/2755614