提示: 手机请竖屏浏览!

早产儿脐带延迟夹闭与立即夹闭的比较
Delayed versus Immediate Cord Clamping in Preterm Infants


William Tarnow-Mordi ... 妇产科和儿科 • 2017.12.21

30周前早产儿延迟脐带结扎获益不显

 

陈倩

北京大学第一医院妇产科

 

有关胎儿(尤其是早产儿)娩出后脐带结扎是立即结扎还是延迟结扎,一直是近年来学术界争论的热点话题。2017年《新英格兰医学杂志》(NEJM)发表了一篇多中心随机对照临床研究论文,对这个问题进行了探讨1

查看更多

摘要


背景

早产儿脐带夹闭的首选时机尚未明确。

 

方法

我们将预期在30周孕龄前分娩的胎儿随机分组,分为脐带立即夹闭(分娩后≤10秒)或延迟夹闭(分娩后≥60秒)。主要复合结局是截至产妇停经后36周龄的死亡或重大疾病(定义为出生后超声检查提示重度脑损伤、重度早产儿视网膜病变、坏死性小肠结肠炎或迟发性脓毒症)。分析基于意向性治疗,考虑多胎妊娠。

 

结果

在1,634例经随机分组的胎儿中,1,566例在孕龄不足30周时活产;本研究分配其中782例接受脐带立即夹闭,784例接受脐带延迟夹闭。在立即夹闭组和延迟夹闭组中,分娩和脐带夹闭的间隔时间中位值分别为5秒和60秒。获得了1,497例婴儿(95.6%)主要结局的完整数据。延迟夹闭组婴儿和立即夹闭组婴儿主要结局的发生率无显著差异(37.0% vs. 37.2%)(相对危险度,1.00;95%置信区间[CI],0.88~1.13;P=0.96)。延迟夹闭组的死亡率为6.4%,立即夹闭组为9.0%(未校正的分析,P=0.03;对多重次要结局进行事后校正后,P=0.39)。慢性肺疾病或其他重大疾病的发生率无显著组间差异。

 

结论

在早产儿中,脐带延迟夹闭与脐带立即夹闭相比,复合结局(截至产妇停经后36周龄的死亡或重大疾病)发生率并未降低(由澳大利亚国家健康与医学研究委员会[Australian National Health and Medical Research Council,NHMRC]和NHMRC临床试验中心[NHMRC Clinical Trials Centre]资助;APTS在澳大利亚和新西兰临床试验注册中心[Australian and New Zealand Clinical Trials Registry]的注册号为ACTRN12610000633088)。





作者信息

William Tarnow-Mordi, M.B., Ch.B., Jonathan Morris, Ph.D., Adrienne Kirby, M.Sc., Kristy Robledo, M.Biostat., Lisa Askie, Ph.D., Rebecca Brown, B.Sc., Nicholas Evans, M.D., Sarah Finlayson, B.Adv.Sc., Michael Fogarty, B.Bmed., Val Gebski, M.Sc., Alpana Ghadge, Ph.D., Wendy Hague, Ph.D., David Isaacs, M.D., Michelle Jeffery, R.N., Anthony Keech, M.B., B.S., Martin Kluckow, Ph.D., Himanshu Popat, M.B., B.S., Lucille Sebastian, Ph.D., Kjersti Aagaard, M.D., Michael Belfort, M.D., Mohan Pammi, M.D., Mohamed Abdel-Latif, M.D., Graham Reynolds, M.B., B.S., Shabina Ariff, M.B., B.S., Lumaan Sheikh, M.B., B.S., Yan Chen, M.Epi., Paul Colditz, D.Phil., Helen Liley, M.B., Ch.B., Margo Pritchard, Ph.D., Daniele de Luca, M.D., Koert de Waal, Ph.D., Peta Forder, M.Biostat., Lelia Duley, M.D., Walid El-Naggar, M.D., Andrew Gill, M.B., B.S., John Newnham, M.D., Karen Simmer, Ph.D., Katie Groom, M.B., B.S., Philip Weston, M.B., B.S., Joanna Gullam, M.B., B.S., Harshad Patel, M.B., B.S., Guan Koh, M.D., Kei Lui, M.D., Neil Marlow, M.D., Scott Morris, M.B., B.S., Arvind Sehgal, Ph.D., Euan Wallace, M.D., Roger Soll, M.D., Leslie Young, M.D., David Sweet, M.B., B.S., Susan Walker, M.D., Andrew Watkins, M.B., B.S., Ian Wright, M.B., B.S., David Osborn, Ph.D., and John Simes, M.D. for the Australian Placental Transfusion Study Collaborative Group*
From the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (W.T.-M., A. Kirby, K.R., L.A., R.B., S.F., V.G., A. Ghadge, W.H., A. Keech, L. Sebastian, J.S.), University of Sydney (J.M., N.E., M.F., D.I., M.J., M.K., H. Popat, H.L., D.O.), Royal North Shore Hospital (Y.C.), and University of New South Wales (K.L.), Sydney, Australian National University, Canberra (M.A.-L., G.R.), University of Queensland, Brisbane (P.C., H.L., M. Pritchard), James Cook University, Cairns (G.K.), University of Western Australia, Perth (A. Gill, J.N., K.S.), Flinders University, Adelaide (S.M.), Monash University (A.S., E.W.) and University of Melbourne (S.W.), Melbourne, Mercy Hospital for Women, Heidelberg (A.W.), and University of Newcastle, Newcastle (K.W., P.F.), and University of Wollongong, Wollongong (I.W.) — all in Australia; Baylor College of Medicine, Houston (K.A., M.B., M. Pammi); Aga Khan University Hospital, Karachi, Pakistan (S.A., L. Sheikh); Hôpital Antoine-Beclere, Clamart, France (D.L.); University of Nottingham, Nottingham, United Kingdom (L.D.); Dalhousie University, Halifax, NS, Canada (W.E.-N.); University of Auckland, Auckland (K.G.), and University of Otago, Dunedin (P.W., J.G., H. Patel) — both in New Zealand; University College London, London (N.M.), and Royal Jubilee Maternity Hospital, Belfast (D.S.) — both in the United Kingdom; and University of Vermont, Burlington (R.S., L.Y.). Address reprint requests to Dr. Tarnow-Mordi at williamtm@med.usyd.edu.au. *A full list of investigators in the Australian Placental Transfusion Study Collaborative Group is provided in the Supplementary Appendix, available at NEJM.org.

 

参考文献

1. Rabe H, Diaz-Rossello JL, Duley L, Dowswell T. Effect of timing of umbilical cord clamping and other strategies to influence placental transfusion at preterm birth on maternal and infant outcomes. Cochrane Database Syst Rev 2012;8:CD003248-CD003248

2. Manley BJ, Owen LS, Hooper SB, et al. Towards evidence-based resuscitation of the newborn infant. Lancet 2017;389:1639-1648

3. Farrar D, Tuffnell D, Airey R, Duley L. Care during the third stage of labour: a postal survey of UK midwives and obstetricians. BMC Pregnancy Childbirth 2010;10:23-23

4. Committee on Obstetric Practice, American College of Obstetricians and Gynecologists. Committee opinion no. 543: timing of umbilical cord clamping after birth. Obstet Gynecol 2012;120:1522-1526

5. Rabe H, Reynolds G, Diaz-Rossello J. A systematic review and meta-analysis of a brief delay in clamping the umbilical cord of preterm infants. Neonatology 2008;93:138-144

6. Strauss RG, Mock DM, Johnson KJ, et al. A randomized clinical trial comparing immediate versus delayed clamping of the umbilical cord in preterm infants: short-term clinical and laboratory endpoints. Transfusion 2008;48:658-665

7. Backes CH, Rivera BK, Haque U, et al. Placental transfusion strategies in very preterm neonates: a systematic review and meta-analysis. Obstet Gynecol 2014;124:47-56

8. Tarnow-Mordi WO, Duley L, Field D, et al. Timing of cord clamping in very preterm infants: more evidence is needed. Am J Obstet Gynecol 2014;211:118-123

9. Ghavam S, Batra D, Mercer J, et al. Effects of placental transfusion in extremely low birthweight infants: meta-analysis of long- and short-term outcomes. Transfusion 2014;54:1192-1198

10. Wyllie J, Perlman JM, Kattwinkel J, et al. Neonatal resuscitation: 2015 international consensus on cardiopulmonary resuscitation and emergency cardiovascular care science with treatment recommendations. Resuscitation 2015;95:e169-e201

11. Wyckoff MH, Aziz K, Escobedo MB, et al. Neonatal resuscitation: 2015 American Heart Association guidelines update for cardiopulmonary resuscitation and emergency cardiovascular care (reprint). Pediatrics 2015;136:Suppl 2:S196-S218

12. Sweet DG, Carnielli V, Greisen G, et al. European consensus guidelines on the management of neonatal respiratory distress syndrome in preterm infants — 2013 update. Neonatology 2013;103:353-368

13. Sweet DG, Carnielli V, Greisen G, et al. European consensus guidelines on the management of respiratory distress syndrome — 2016 update. Neonatology 2017;111:107-125

14. National Institute for Health and Care Excellence. Preterm labour and birth: NICE guideline. London: NICE, 2015 (https://www.nice.org.uk/guidance/ng25).

15. Jelin AC, Kuppermann M, Erickson K, Clyman R, Schulkin J. Obstetricians’ attitudes and beliefs regarding umbilical cord clamping. J Matern Fetal Neonatal Med 2014;27:1457-1461

16. Jelin AC, Zlatnik MG, Kuppermann M, Gregorich SE, Nakagawa S, Clyman R. Clamp late and maintain perfusion (CLAMP) policy: delayed cord clamping in preterm infants. J Matern Fetal Neonatal Med 2016;29:1705-1709

17. Tarnow-Mordi W, Cruz M, Morris J. Design and conduct of a large obstetric or neonatal randomized controlled trial. Semin Fetal Neonatal Med 2015;20:389-402

18. Australian and New Zealand Neonatal Network. ANZNN 2009 data dictionary. Sydney: UNSW, 2008.

19. Australian and New Zealand Neonatal Network. ANZNN 2009/2010 follow-up data dictionary. Sydney: UNSW, 2013.

20. Doyle LW, Carse E, Adams A-M, Ranganathan S, Opie G, Cheong JLY. Ventilation in extremely preterm infants and respiratory function at 8 years. N Engl J Med 2017;377:329-337

21. Manley BJ, Owen LS, Doyle LW, et al. High-flow nasal cannulae in very preterm infants after extubation. N Engl J Med 2013;369:1425-1433

22. Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med 2001;163:1723-1729

23. Gagliardi L, Bellù R, Lista G, Zanini R, Network Neonatale Lombardo Study Group. . Do differences in delivery room intubation explain different rates of bronchopulmonary dysplasia between hospitals? Arch Dis Child Fetal Neonatal Ed 2011;96:F30-F35

24. Medlock S, Ravelli AC, Tamminga P, Mol BW, Abu-Hanna A. Prediction of mortality in very premature infants: a systematic review of prediction models. PLoS One 2011;6:e23441-e23441

25. Li F, Wu T, Lei X, Zhang H, Mao M, Zhang J. The Apgar score and infant mortality. PLoS One 2013;8:e69072-e69072

26. Haybittle JL. Repeated assessment of results in clinical trials of cancer treatment. Br J Radiol 1971;44:793-797

27. Peto R, Pike MC, Armitage P, et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design. Br J Cancer 1976;34:585-612

28. DAMOCLES Study Group, NHS Health Technology Assessment Programme. A proposed charter for clinical trial data monitoring committees: helping them to do their job well. Lancet 2005;365:711-722

29. Davis CS. Statistical methods for the analysis of repeated measurements. New York: Springer-Verlag, 2002.

30. Benjamini Y, Hochberg Y. Controlling the false discovery rate: a practical and powerful approach to multiple testing. J R Stat Soc B 1995;57:289-300

31. Pocock SJ, Stone GW. The primary outcome fails — what next? N Engl J Med 2016;375:861-870

32. Clarke M, Hopewell S, Chalmers I. Reports of clinical trials should begin and end with up-to-date systematic reviews of other relevant evidence: a status report. J R Soc Med 2007;100:187-190

33. Tarnow-Mordi W, Cruz M, Morris JM, Mol BW. RCT evidence should drive clinical practice: a day without randomisation is a day without progress. BJOG 2017;124:613-613

34. Popat H, Robledo KP, Sebastian L, et al. Effect of delayed cord clamping on systemic blood flow: a randomized controlled trial. J Pediatr 2016;178:81-86.e2

35. Peto R, Baigent C. Trials: the next 50 years: large scale randomised evidence of moderate benefits. BMJ 1998;317:1170-1171

36. Eisenstein EL, Collins R, Cracknell BS, et al. Sensible approaches for reducing clinical trial costs. Clin Trials 2008;5:75-84

服务条款 | 隐私政策 | 联系我们