Delayed versus Immediate Cord Clamping in Preterm Infants

被引:208
作者
Tarnow-Mordi, W. [1 ]
Morris, J. [2 ]
Kirby, A. [1 ]
Robledo, K. [1 ]
Askie, L. [1 ]
Brown, R. [1 ]
Evans, N. [2 ]
Finlayson, S. [1 ]
Fogarty, M. [2 ]
Gebski, V. [1 ]
Ghadge, A. [1 ]
Hague, W. [1 ]
Isaacs, D. [2 ]
Jeffery, M. [2 ]
Keech, A. [1 ]
Kluckow, M. [2 ]
Popat, H. [2 ]
Sebastian, L. [1 ]
Aagaard, K. [15 ]
Belfort, M. [15 ]
Pammi, M. [15 ]
Abdel-Latif, M. [5 ]
Reynolds, G. [5 ]
Ariff, S. [16 ]
Sheikh, L. [16 ]
Chen, Y. [3 ]
Colditz, P. [6 ]
Liley, H. [2 ,6 ]
Pritchard, M. [6 ]
de Luca, D. [17 ]
de Waal, K. [13 ]
Forder, P. [13 ]
Duley, L. [18 ]
El-Naggar, W. [19 ]
Gill, A. [8 ]
Newnham, J. [8 ]
Simmer, K. [8 ]
Groom, K. [20 ]
Weston, P. [21 ]
Gullam, J. [21 ]
Patel, H. [21 ]
Koh, G. [7 ]
Lui, K. [4 ]
Marlow, N. [22 ]
Morris, S. [9 ]
Sehgal, A. [10 ]
Wallace, E. [10 ]
Soll, R. [24 ]
Young, L. [24 ]
Sweet, D. [23 ]
机构
[1] Univ Sydney, Natl Hlth & Med Res Council Clin Trials Ctr, Sydney, NSW, Australia
[2] Univ Sydney, Sydney, NSW, Australia
[3] Royal North Shore Hosp, Sydney, NSW, Australia
[4] Univ New South Wales, Sydney, NSW, Australia
[5] Australian Natl Univ, Canberra, ACT, Australia
[6] Univ Queensland, Brisbane, Qld, Australia
[7] James Cook Univ, Cairns, Australia
[8] Univ Western Australia, Perth, WA, Australia
[9] Flinders Univ S Australia, Adelaide, SA, Australia
[10] Monash Univ, Clayton, Vic, Australia
[11] Univ Melbourne, Melbourne, Vic, Australia
[12] Mercy Hosp Women, Heidelberg, Vic, Australia
[13] Univ Newcastle, Newcastle, NSW, Australia
[14] Univ Wollongong, Wollongong, NSW, Australia
[15] Baylor Coll Med, Houston, TX 77030 USA
[16] Aga Khan Univ Hosp, Karachi, Pakistan
[17] Hop Antoine Beclere, Clamart, France
[18] Univ Nottingham, Nottingham, England
[19] Dalhousie Univ, Halifax, NS, Canada
[20] Univ Auckland, Auckland, New Zealand
[21] Univ Otago, Dunedin, New Zealand
[22] UCL, London, England
[23] Royal Jubilee Matern Hosp, Belfast, Antrim, North Ireland
[24] Univ Vermont, Burlington, VT 05405 USA
基金
英国医学研究理事会; 澳大利亚国家健康与医学研究理事会;
关键词
HEMATOPOIETIC-CELL TRANSPLANTATION; PREVENT CYTOMEGALOVIRUS DISEASE; ANTICYTOMEGALOVIRUS COMPOUND AIC246; IN-VITRO; MARROW-TRANSPLANTATION; DOUBLE-BLIND; GANCICLOVIR PROPHYLAXIS; MARIBAVIR PROPHYLAXIS; LETERMOVIR RESISTANCE; PREEMPTIVE TREATMENT;
D O I
10.1056/NEJMoa1711281
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
BACKGROUND The preferred timing of umbilical-cord clamping in preterm infants is unclear. METHODS We randomly assigned fetuses from women who were expected to deliver before 30 weeks of gestation to either immediate clamping of the umbilical cord (<= 10 seconds after delivery) or delayed clamping (60 seconds after delivery). The primary composite outcome was death or major morbidity (defined as severe brain injury on postnatal ultrasonography, severe retinopathy of prematurity, necrotizing enterocolitis, or late-onset sepsis) by 36 weeks of postmenstrual age. Analyses were performed on an intention-to-treat basis, accounting for multiple births. RESULTS Of 1634 fetuses that underwent randomization, 1566 were born alive before 30 weeks of gestation; of these, 782 were assigned to immediate cord clamping and 784 to delayed cord clamping. The median time between delivery and cord clamping was 5 seconds and 60 seconds in the respective groups. Complete data on the primary outcome were available for 1497 infants (95.6%). There was no significant difference in the incidence of the primary outcome between infants assigned to delayed clamping (37.0%) and those assigned to immediate clamping (37.2%) (relative risk, 1.00; 95% confidence interval, 0.88 to 1.13; P = 0.96). The mortality was 6.4% in the delayed-clamping group and 9.0% in the immediate-clamping group (P = 0.03 in unadjusted analyses; P = 0.39 after post hoc adjustment for multiple secondary outcomes). There were no significant differences between the two groups in the incidences of chronic lung disease or other major morbidities. CONCLUSIONS Among preterm infants, delayed cord clamping did not result in a lower incidence of the combined outcome of death or major morbidity at 36 weeks of gestation than immediate cord clamping. (Funded by the Australian National Health and Medical Research Council [NHMRC] and the NHMRC Clinical Trials Centre; APTS Australian and New Zealand Clinical Trials Registry number, ACTRN12610000633088.)
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页码:2445 / 2455
页数:11
相关论文
共 42 条
[11]   Geno- and Phenotypic Characterization of Human Cytomegalovirus Mutants Selected In Vitro after Letermovir (AIC246) Exposure [J].
Goldner, Thomas ;
Hempel, Christine ;
Ruebsamen-Schaeff, Helga ;
Zimmermann, Holger ;
Lischka, Peter .
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, 2014, 58 (01) :610-613
[12]   The Novel Anticytomegalovirus Compound AIC246 (Letermovir) Inhibits Human Cytomegalovirus Replication through a Specific Antiviral Mechanism That Involves the Viral Terminase [J].
Goldner, Thomas ;
Hewlett, Guy ;
Ettischer, Nicole ;
Ruebsamen-Schaeff, Helga ;
Zimmermann, Holger ;
Lischka, Peter .
JOURNAL OF VIROLOGY, 2011, 85 (20) :10884-10893
[13]   GANCICLOVIR PROPHYLAXIS TO PREVENT CYTOMEGALOVIRUS DISEASE AFTER ALLOGENEIC MARROW TRANSPLANT [J].
GOODRICH, JM ;
BOWDEN, RA ;
FISHER, L ;
KELLER, C ;
SCHOCH, G ;
MEYERS, JD .
ANNALS OF INTERNAL MEDICINE, 1993, 118 (03) :173-178
[14]   EARLY TREATMENT WITH GANCICLOVIR TO PREVENT CYTOMEGALOVIRUS DISEASE AFTER ALLOGENEIC BONE-MARROW TRANSPLANTATION [J].
GOODRICH, JM ;
MORI, M ;
GLEAVES, CA ;
DUMOND, C ;
CAYS, M ;
EBELING, DF ;
BUHLES, WC ;
DEARMOND, B ;
MEYERS, JD .
NEW ENGLAND JOURNAL OF MEDICINE, 1991, 325 (23) :1601-1607
[15]   Efficacy of a Viral Load-Based, Risk-Adapted, Preemptive Treatment Strategy for Prevention of Cytomegalovirus Disease after Hematopoietic Cell Transplantation [J].
Green, Margaret L. ;
Leisenring, Wendy ;
Stachel, Daniel ;
Pergam, Steven A. ;
Sandmaier, Brenda M. ;
Wald, Anna ;
Corey, Lawrence ;
Boeckh, Michael .
BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION, 2012, 18 (11) :1687-1699
[16]  
Hodson EM, 2013, COCHRANE DB SYST REV, V2
[17]   The Efficacy and Safety of 200 Days Valganciclovir Cytomegalovirus Prophylaxis in High-Risk Kidney Transplant Recipients [J].
Humar, A. ;
Lebranchu, Y. ;
Vincenti, F. ;
Blumberg, E. A. ;
Punch, J. D. ;
Limaye, A. P. ;
Abramowicz, D. ;
Jardine, A. G. ;
Voulgari, A. T. ;
Ives, J. ;
Hauser, I. A. ;
Peeters, P. .
AMERICAN JOURNAL OF TRANSPLANTATION, 2010, 10 (05) :1228-1237
[18]   First Report of Successful Treatment of Multidrug-Resistant Cytomegalovirus Disease with the Novel Anti-CMV Compound AIC246 [J].
Kaul, D. R. ;
Stoelben, S. ;
Cober, E. ;
Ojo, T. ;
Sandusky, E. ;
Lischka, P. ;
Zimmermann, H. ;
Rubsamen-Schaeff, H. .
AMERICAN JOURNAL OF TRANSPLANTATION, 2011, 11 (05) :1079-1084
[19]   Valganciclovir for Symptomatic Congenital Cytomegalovirus Disease [J].
Kimberlin, D. W. ;
Jester, P. M. ;
Sanchez, P. J. ;
Ahmed, A. ;
Arav-Boger, R. ;
Michaels, M. G. ;
Ashouri, N. ;
Englund, J. A. ;
Estrada, B. ;
Jacobs, R. F. ;
Romero, J. R. ;
Sood, S. K. ;
Whitworth, M. S. ;
Abzug, M. J. ;
Caserta, M. T. ;
Fowler, S. ;
Lujan-Zilbermann, J. ;
Storch, G. A. ;
DeBiasi, R. L. ;
Han, J. -Y. ;
Palmer, A. ;
Weiner, L. B. ;
Bocchini, J. A. ;
Dennehy, P. H. ;
Finn, A. ;
Griffiths, P. D. ;
Luck, S. ;
Gutierrez, K. ;
Halasa, N. ;
Homans, J. ;
Shane, A. L. ;
Sharland, M. ;
Simonsen, K. ;
Vanchiere, J. A. ;
Woods, C. R. ;
Sabo, D. L. ;
Aban, I. ;
Kuo, H. ;
James, S. H. ;
Prichard, M. N. ;
Griffin, J. ;
Giles, D. ;
Acosta, E. P. ;
Whitley, R. J. .
NEW ENGLAND JOURNAL OF MEDICINE, 2015, 372 (10) :933-943
[20]   Characterization of Cytomegalovirus Breakthrough Events in a Phase 2 Prophylaxis Trial of Letermovir (AIC246, MK 8228) [J].
Lischka, Peter ;
Michel, Detlef ;
Zimmermann, Holger .
JOURNAL OF INFECTIOUS DISEASES, 2016, 213 (01) :23-30