Extreme Caution Is Needed Before Scale-Up of Antenatal Corticosteroids to and Intensive Care in Two Studies Risk

Correspondence Antenatal distress in infants at 34 weeks’ several of the concerns expressed in corticosteroids to gestation. This statement is based on the Comment by Azad and Costello a subgroup analysis from a systematic will be addressed. 3 reduce preterm deaths review. However, the same review We declare that we have no competing interests. presents data showing a decreased in low-income settings Copyright © Althabe et al. Open Access article risk of respiratory distress syndrome distributed under the terms of CC BY-NC-ND. In their Comment (April issue),1 in infants with first dose of cortico- Fernando Althabe, José M Belizán, Kishwar Azad and Anthony Costello steroids administered to mothers Pierre Buekens, *Elizabeth M McClure, raise questions that should be answered at 33–35 weeks’ gestation (relative Marion Koso-thomas, on behalf of the before antenatal corticosteroid treat- risk [RR] 0·53, 95% CI 0·31–0·91), NICHD’s Global Network for Women’s ment is scaled up to reduce pre term and a non-signifi cant decrease in the and Children’s Health Research ACT deaths in low-income countries. We risk of respiratory distress in infants Trial Steering Committee share their concerns about the unknown (0·61, 0·11–3·26) with first dose at [email protected] overall effect of this treatment on 35–37 weeks’ gestation. The fi ndings Institute for Clinical Eff ectiveness and Health Policy, mortality and potential safety issues in suggest a reduction in respiratory Buenos Aires, Argentina (FA, JMB); Tulane School of the mother. To answer these questions, distress syndrome is present according Public Health and Tropical Medicine, New Orleans, we have initiated the Antenatal to gestational age at fi rst delivery of LA, USA (PB); RTI International, 3040 Cornwallis Drive, Durham, NC, 27709, USA (EMM); Eunice 2 3 Corticosteroids Trial to assess whether corticosteroids. Kennedy Shriver National Institute of Child Health or not a multifaceted intervention Prevention of respiratory distress and Human Development, Rockville MD, USA (MK-T) to increase the use of antenatal syndrome in infants born at 1 Azad K, Costello A. Extreme caution is needed corticosteroids reduces neonatal 33–36 weeks’ gestation without access before scale-up of antenatal corticosteroids to reduce preterm deaths in low-income settings. mortality at 28 days of age, and to specialised high-quality level 2 care Lancet Glob Health 2014; 2: e191–92. maternal morbidity due to infections. might create a substantial health-care 2 Althabe F, Belizán JM, Mazzoni A, et al. Antenatal corticosteroids trial in preterm births to increase Enrolment has been completed and burden in low-income countries. The neonatal survival in developing countries: study data from more than 90 000 births have Antenatal Corticosteroids Trial2 will protocol. Reprod Health 2012; 9: 22. been collected. assess the administration of steroids 3 Roberts D, Dalziel SR. Antenatal corticosteroids for accelerating fetal lung maturation for We disagree with Azad and Costello’s to mothers up to 36 weeks’ gestation. women at risk of preterm birth. comment about the eff ect of antenatal Data from this trial will be available in Cochrane Database Syst Rev 2006; 3: CD004454. corticosteroid treatment on respiratory the second half of 2014. We hope that www.thelancet.com/lancetgh Vol 2 August 2014 e444 Correspondence Antenatal done as part of a trial, and focuses only corticosteroids are likely to have a corticosteroids to on quality improvement, we noted greater eff ect in the absence of level 2 no increase in the rate of maternal or care, not a lesser eff ect.4 The diff erence reduce preterm deaths neonatal infections. between low-income and high-income in low-income settings Antenatal corticosteroids induce fetal settings is not biology, but an increased lung maturation through the same burden of disease and reduced access to The Comment1 by Kishwar Azad and biological mechanism in low-income even basic health care. Our experience Anthony Costello opposing scale- settings as in high-income settings in Malawi off ers a powerful example for up of antenatal corticosteroids and reduce the need for neonatal generalising this standard of care to the misdirects the discussion of this mechanical ventilation.3 Although regions where it will save the most lives topic towards speculation about antenatal corticosteroids might not be and also reduce neonatal disability. differences in low-income settings. a so-called magic bullet as a standalone I declare no competing interests. Our experience in Malawi provides vertical intervention, no biological Copyright © Kaliti. Open Access article distributed a concrete example of the rapid basis exists to presume that babies under the terms of CC BY-NC-ND. scaling up of antenatal corticosteroid born preterm in resource-poor settings Stephen Kaliti treatment with dexamethasone. will succumb to respiratory distress [email protected] Malawi has the highest estimated syndrome any more than do those in 2 Bwaila Maternity Hospital, Obstetrics and preterm birth rate worldwide. In resource-rich countries. I support the Gynecology, Malanga Langa Road, Lilongwe, Malawi Bwaila Maternity Hospital, Lilongwe, existing recommendation of a single- 1 Azad K, Costello A. Extreme caution is needed that has more than 15 000 deliveries course of antenatal corticosteroids to before scale-up of antenatal corticosteroids to annually with more than 2900 preterm, mothers at high risk of preterm birth reduce preterm deaths in low-income settings. Lancet Glob Health 2014; 2: e191–92. we increased targeted coverage of between 24 weeks and 33 weeks’ 2 Blencowe H, Cousens S, Oestergaard M, et al. antenatal corticosteroids from 8% to gestation, but question Azad and National, regional and worldwide estimates of 80% in 16 weeks in women at risk of Costello’s unrealistic prerequisite for preterm birth rates in the year 2010 with time trends for selected countries since 1990: preterm delivery from 24 to 34 weeks’ round-the-clock access to level 2 care in a systematic analysis and implications. Lancet gestation. After this pilot study, we a low-income setting. 2012; 9832: 2162–72. 3 Roberts D, Dalziel S. Antenatal corticosteroids for began programmes in three other Low-income settings, which have the accelerating fetal lung maturation for women at hospitals, reaching 59–83% coverage highest burden of preterm neonatal risk of preterm birth. Cochrane Database Syst Rev from a baseline of 1–6% within 6 weeks. deaths, urgently need proven benefi cial 2006, 3: CD00004454. 4 Mwansa-Kambafwile J, Cousens S, Hansen T, This intervention has thus far been interventions, not the assessment Lawn JE. Antenatal steroids in preterm labour associated with a drop in preterm of therapeutic efficacy on the basis for the prevention of neonatal deaths due to complications of preterm birth. Int J Epidemiol neonatal mortality contribution of resource profi ling that could delay 2010; 39: 1122–33. from 60% to 24% at 0–6 days of age. treatment. Contrary to Azad and Although this intervention was not Costello’s speculation,1 antenatal www.thelancet.com/lancetgh Vol 2 August 2014 e445 Correspondence Antenatal of prematurity so their concerns with of antenatal corticosteroids. We support corticosteroids to respect to perinatal death or disability the call for more research, especially are hard to justify. Repeat antenatal on how to reach the poorest women reduce preterm deaths corticosteroids have been linked to and how to increase long-term health in low-income settings learning disabilities compared with a for both women and their babies. In single dose,4 and late-onset metabolic the meantime, the evidence strongly Kishwar Azad and Anthony Costello1 syndrome might also be a risk.5 With supports giving a single, short course suggest the use of extreme caution in respect to maternal outcomes there of corticosteroids to women at risk of scaling up of antenatal corticosteroid is no robust evidence of increased preterm birth in hospitals everywhere, treatment in low-income settings. infections.6 Because preterm deaths are not just in high-income countries. They raise three important questions now the leading cause of child deaths at Prof Joy E Lawn is co-lead of ACS Technical with respect to the effi cacy, safety, 1 million per year, the balance lies in the Reference Team for UN Commission on Life Saving and the appropriate gestational age direction of reducing mortality rather Commodities and wrote this Correspondence on behalf of the group. at which to give corticosteroids to than the unknown risks of less severe Copyright © Lawn et al. Open Access article patients in low-income countries. outcomes. distributed under the terms of CC BY-NC-ND. Firstly, in terms of efficacy, there Thirdly, although the proven benefi t *Joy E Lawn, Joel Segre, Pierre Barker, is high-quality evidence on the of antenatal corticosteroids is when Jeff rey Smith, Irene De La Torre, benefits of antenatal corticosteroids they are administered to patients William Stones for lung maturation in utero. A large at 28–33 weeks’ gestation, this [email protected] decrease in neonatal mortality was gestational age band is partly due London School Hygiene and Tropical Medicine, reported in trials in four middle- to enrolment criteria in the original University College London, UK and Save the Children, income countries, including those in trials.2,3 The gestational-age limit for South Africa (JEL); Consultant to Bill & Melinda Gates Africa and the Middle East (relative antenatal corticosteroids in high- Foundation, Seattle, WA, USA (JS); Institute for Healthcare Improvement, Cambridge, MA, USA and risk [RR] 0·47, 95% CI 0·35–0·64), income countries has been extended Gillings School of Global Public Health, University of compared with 14 studies in high- with guidelines supporting use at North Carolina Chapel Hill, NC, USA (PB); Jhpiego, income countries (0·79, 0·65–0·96).2,3 less than 26 weeks’ gestation.

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