Bora Rajib Losan, Bandyopadhyay Sambhunath, Saha Bijan, Mukherjee Suchandra, Hazra Abhijit
Department of Neonatology, IPGME&R and SSKM Hospital, Kolkata, West Bengal, India.
Department of Obstetrics and Gynaecology, IPGME&R and SSKM Hospital, Kolkata, West Bengal, India.
Eur J Pediatr. 2023 Sep;182(9):3883-3891. doi: 10.1007/s00431-023-05063-4. Epub 2023 Jun 19.
Routine practice of delayed cord clamping (DCC) is the standard of care in vigorous neonates. However there is no consensus on the recommended approach to placental transfusion in non-vigorous neonates. In this trial, we tried to examine the effect of cut umbilical cord milking (C-UCM) as compared to early cord clamping (ECC) on hematological and clinical hemodynamic parameters in non-vigorous preterm neonates of 30-35 weeks gestation. The primary outcome assessed was venous hematocrit (Hct) at 48 (± 4) hours of postnatal age. The important secondary outcomes assessed were serum ferritin at 6 weeks of age, mean blood pressure in the initial transitional phase along with important neonatal morbidities and potential complications. In this single centre randomized controlled trial, 134 non vigorous neonates of 30-35 weeks gestation were allocated in a 1:1 ratio to either C-UCM (n = 67) or ECC (n = 67). For statistical analysis, unpaired Student t and Chi square or Fisher's exact test were used. The mean Hct at 48 h was higher in the C-UCM group as compared to the control group, 50.24(4.200) vs 46.16(2.957), p < .0001. Also significantly higher was the mean Hct at 12 h, 6 weeks and mean serum ferritin at 6 weeks of age in the milked group (p < .0001). Mean blood pressure at 1 h and 6 h was also significantly higher in the milked arm. Need for transfusion and inotropes was less in the milked group but not statistically significant. No significant difference in potential complications was observed between the groups. Conclusion: C-UCM stabilizes initial blood pressure and results in higher hematocrit and improved iron stores. It can be an alternative to DCC in non-vigorous preterm neonates of 30-35 weeks' gestation. Further large multicentric studies are needed to fully establish its efficacy and safety. Trial registration: CTRI/2021/12/038606; registration date December 14, 2021. What is Known: • DCC is the routinely recommended method of placental transfusion for vigorous neonates but no consensus exist for neonates requiring resuscitation at birth. • C-UCM is easier to perform in non-vigorous neonates but there is paucity of studies in the preterm population. What is New: • C-UCM is effective as well as safe in non-vigorous preterm neonates of 30-35 weeks gestational age. • C-UCM holds promise as an alternative to DCC, especially in resource limited settings and in situations where the later is not feasible.
延迟脐带结扎(DCC)的常规做法是活力新生儿的标准治疗方法。然而,对于非活力新生儿胎盘输血的推荐方法尚无共识。在本试验中,我们试图研究与早期脐带结扎(ECC)相比,断脐挤奶(C-UCM)对孕周为30-35周的非活力早产新生儿血液学和临床血流动力学参数的影响。评估的主要结局是出生后48(±4)小时的静脉血细胞比容(Hct)。评估的重要次要结局是6周龄时的血清铁蛋白、初始过渡阶段的平均血压以及重要的新生儿疾病和潜在并发症。在这项单中心随机对照试验中,134例孕周为30-35周的非活力新生儿按1:1比例分为C-UCM组(n = 67)或ECC组(n = 67)。进行统计分析时,使用了非配对学生t检验、卡方检验或Fisher精确检验。与对照组相比,C-UCM组48小时时的平均Hct更高,分别为50.24(4.200)和46.16(2.957),p <.0001。挤奶组12小时、6周时的平均Hct以及6周龄时的平均血清铁蛋白也显著更高(p <.0001)。挤奶组1小时和6小时时的平均血压也显著更高。挤奶组输血和使用血管活性药物的需求较少,但无统计学意义。两组间潜在并发症无显著差异。结论:C-UCM可稳定初始血压,提高血细胞比容并改善铁储备。对于孕周为30-35周的非活力早产新生儿,它可作为DCC的替代方法。需要进一步开展大型多中心研究以充分确立其疗效和安全性。试验注册号:CTRI/2021/12/038606;注册日期:2021年12月14日。已知信息:• DCC是活力新生儿常规推荐的胎盘输血方法,但对于出生时需要复苏的新生儿尚无共识。• C-UCM在非活力新生儿中更易于实施,但早产人群的研究较少。新发现:• C-UCM对于孕周为30-35周的非活力早产新生儿有效且安全。• C-UCM有望成为DCC的替代方法,尤其是在资源有限的环境以及DCC不可行的情况下。