Maternal intramuscular dexamethasone versus betamethasone before preterm birth (ASTEROID): a multicentre, double-blind, randomised controlled trial

被引：58

作者：

Crowther, Caroline A. ^{[1
,2
,9
]}

Ashwood, Pat ^{[2
,9
,23
]}

Andersen, Chad C. ^{[3
,9
,23
]}

Middleton, Philippa F. ^{[2
,4
,9
]}

Thach Tran ^{[5
,9
]}

Doyle, Lex W. ^{[6
,7
,8
]}

Robinson, Jeffrey S. ^{[2
,9
]}

Harding, Jane E. ^{[1
,10
]}

Ball, Vincent ^{[9
]}

Holst, Carol ^{[9
]}

Robinson, Kaye ^{[9
]}

Zhang, Sasha ^{[9
]}

Khong, Yee ^{[9
]}

McPhee, Andrew ^{[9
]}

Groom, Katie ^{[10
]}

Alsweiler, Jane ^{[10
]}

Eaglen, Deb ^{[10
]}

Hauch, Helga ^{[10
]}

Vallely, Alenna ^{[10
]}

Angus, Sonia ^{[11
]}

Chenia, Feisal ^{[11
]}

Drew, Alison ^{[12
]}

Gavranich, John ^{[12
]}

Green, Ann ^{[12
]}

Jack, Susan ^{[12
]}

Mahomed, Kassam ^{[12
]}

Sebastian, Rebecca ^{[12
]}

Turner, Laura ^{[12
]}

Baldwin, Michelle ^{[13
]}

Dennis, Amanda ^{[13
]}

Fisher, Eleanor ^{[13
]}

Gee, Karen ^{[13
]}

Gee, Michael ^{[13
]}

Strong, David ^{[13
]}

Boord, Donna ^{[14
]}

Edge, Nicole ^{[14
]}

Marsh, Michelle ^{[14
]}

Staehr, Casie ^{[14
]}

Chaplin, Jackie ^{[15
]}

Gardener, Glenn ^{[15
]}

Gray, Peter ^{[15
]}

Hurrion, Elizabeth ^{[15
]}

Jardine, Luke ^{[15
]}

Kan, Janet ^{[15
]}

Lynn, Lisa ^{[15
]}

Poulsen, Leith ^{[15
]}

Tremellen, Anne ^{[15
]}

Codner, Tracey ^{[16
]}

Cubis, Wendy ^{[16
]}

Downward, Sue ^{[16
]}

机构：

[1] Univ Auddand, Liggins Inst, Auckland 1142, New Zealand

[2] Univ Adelaide, Sch Med, Adelaide, SA, Australia

[3] Womens & Childrens Hosp, Dept Perinatal Med, Adelaide, SA, Australia

[4] South Australian Hlth & Med Res Inst, Adelaide, SA, Australia

[5] Garvan Inst Med Res, Osteoporosis & Bone Biol, Sydney, NSW, Australia

[6] Royal Womens Hosp, Dept Obstet & Gynaecol, Melbourne, Vic, Australia

[7] Univ Melbourne, Dept Paediat, Melbourne, Vic, Australia

[8] Murdoch Childrens Res Inst, Clin Sci, Melbourne, Vic, Australia

[9] Univ Adelaide, Adelaide, SA, Australia

[10] Auckland City Hosp, Auckland, New Zealand

[11] Gawler Hosp, Gawler East, SA, Australia

[12] Ipswich Hosp, Ipswich, Suffolk, England

[13] Launceston Gen Hosp, Launceston, Tas, Australia

[14] Lyell McEwin Hosp, Elizabeth Vale, SA, Australia

[15] Mater Mothers Hosp, South Brisbane, Qld, Australia

[16] Nepean Hosp, Kingswood, NSW, Australia

[17] Royal Hobart Hosp, Hobart, Tas, Australia

[18] Royal Hosp Women, Randwick, NSW, Australia

[19] Royal North Shore Hosp, St Leonards, NSW, Australia

[20] Royal Womens Hosp, Parkville, Vic, Australia

[21] St George Hosp, Kogarah, NSW, Australia

[22] Townsville Hosp, Douglas, Qld, Australia

[23] Womens & Childrens Hosp, Adelaide, SA, Australia

来源：

LANCET CHILD & ADOLESCENT HEALTH | 2019年 / 3卷 / 11期

基金：

英国医学研究理事会;

关键词：

ANTENATAL CORTICOSTEROIDS; WEIGHT INFANTS; CHILDREN; COUNTRIES; MORTALITY; OUTCOMES; INCOME; CARE; AGE;

D O I：

10.1016/S2352-4642(19)30292-5

中图分类号：

R72 [儿科学];

学科分类号：

100202 ;

摘要：

Background Antenatal corticosteroids given to women before preterm birth improve infant survival and health. However, whether dexamethasone or betamethasone have better maternal, neonatal, and childhood health outcomes remains unclear. We therefore aimed to assess whether administration of antenatal dexamethasone to women at risk of preterm birth reduced the risk of death or neurosensory disability in their children at age 2 years compared with betamethasone. We also aimed to assess whether dexamethasone reduced neonatal morbidity, had benefits for the mother, or affected childhood body size, blood pressure, behaviour, or general health compared with betamethasone. Methods In this multicentre, double-blind, randomised controlled trial, we recruited pregnant women from 14 maternity hospitals in Australia and New Zealand that could provide care to preterm babies. Women were eligible for study indusion if they were at risk of preterm birth before 34 weeks of gestation, had a singleton or twin pregnancy, and had no contraindications to antenatal corticosteroids. We randomly assigned women (1:1) to receive two intramuscular injections of either 12 mg dexamethasone (dexamethasone sodium phosphate) or 11.4 mg betamethasone (Celestone Chronodose), 24 h apart. The randomisation schedule used balanced, variable blocks that were stratified by hospital, gestational age, and number of fetuses (singleton or twins). We masked all participants, staff, and assessors to treatment groups. Analyses were by intention to treat. The primary outcome was death or neurosensory disability at age 2 years (corrected for prematurity). This study is registered with ANZCTR, ACTRN12608000631303. Findings Between Jan 28, 2009, and Feb 1, 2013, we randomly assigned 1346 (78%) women who were pregnant with 1509 fetuses to groups: 679 (50%) women were assigned to receive dexamethasone and 667 (50%) women were assigned to receive betamethasone. 27 (4%) fetuses, infants, or children in the dexamethasone group and 28 (4%) fetuses, infants, or children in the betamethasone group died before age 2 years. The primary outcome of death or neurosensory disability at age 2 years was determined for 603 (79%) of 763 fetuses whose mothers received dexamethasone and 591 (79%) of 746 fetuses whose mothers received betamethasone. We found a similar incidence of death or neurosensory disability in the dexamethasone (198 [33%] of 603 infants) and betamethasone groups (192 [32%] of 591 infants; adjusted relative risk [adjRR] 0.97, 95% CI 0.83 to 1.13; p=0.66).18 (3%) of 679 women in the dexamethasone group and 28 of 667 (4%) women in the betamethasone group reported side-effects. Discomfort at the injection site, the most frequent side-effect, was less likely in the dexamethasone group than in the betamethasone group (six [1%] women vs 17 [3%] women; p=0. 02). Interpretation The incidence of survival without neurosensory disability at age 2 years did not differ between dexamethasone and betamethasone treatment. Our findings indicate that either antenatal corticosteroid can be given to women before preterm birth to improve infant and child health. Copyright (C) 2019 Elsevier Ltd. All rights reserved.

引用

页码：769 / 780

页数：12

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