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。
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
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.