Effectiveness of antenatal corticosteroids in reducing respiratory disorders in late preterm infants: randomised clinical trialBMJ 2011; 342 doi: https://doi.org/10.1136/bmj.d1696 (Published 12 April 2011) Cite this as: BMJ 2011;342:d1696
- Ana Maria Feitosa Porto, supervisor of medical residency programme in gynaecology and obstetrics,
- Isabela Cristina Coutinho, preceptor of high risk ward,
- Jailson Barros Correia, research director,
- Melania Maria Ramos Amorim, professor in postgraduate programme on maternal and child health
- Correspondence to: Melania Maria Ramos de Amorim, Rua Neuza Borborema de Souza, 300, Bairro Santo Antônio, 58406-120 Campina Grande, PB, Brazil
- Accepted 30 January 2011
Objectives To determine the effectiveness of corticosteroids in reducing respiratory disorders in infants born at 34-36 weeks’ gestation.
Design Randomised triple blind clinical trial.
Setting A large tertiary teaching hospital in northeast of Brazil.
Participants Women at 34-36 weeks of pregnancy at risk of imminent premature delivery.
Interventions Betamethasone 12 mg or placebo intramuscularly for two consecutive days.
Main outcomes measures Primary outcome was the incidence of respiratory disorders (respiratory distress syndrome and transient tachypnoea of the newborn). Secondary outcomes included the need for ventilatory support, neonatal morbidity, and duration of stay in hospital.
Results 320 women were randomised, 163 of whom were assigned to the treatment group and 157 to the controls. Final analysis included 143 and 130 infants, respectively. The rate of respiratory distress syndrome was low (two (1.4%) in the corticosteroid group; one (0.8%) in the placebo group; P=0.54), while the rate of transient tachypnoea was high in both groups (34 (24%) v 29 (22%); P=0.77). There was no reduction in the risk of respiratory morbidity with corticosteroid use even after adjustment for subgroups of gestational age (34-34+6 weeks, 35-35+6 weeks, and ≥36 weeks). The adjusted risk of respiratory morbidity was 1.12 (95% confidence interval 0.74 to 1.70). The need for ventilatory support was around 20% in both groups. There was no difference in neonatal morbidity (88 (62%) v 93 (72%); P=0.08) or in the duration of stay in hospital between the two groups (5.12 v 5.22 days; P=0.87). Phototherapy for jaundice was required less often in babies whose mothers received corticosteroids (risk ratio 0.63, 0.44 to 0.91).
Conclusions Antenatal treatment with corticosteroids at 34-36 weeks of pregnancy does not reduce the incidence of respiratory disorders in newborn infants.
Trial registration Clinical Trials NCT00675246.
Contributors: AMFP developed the initial protocol, initiated and coordinated the enrolment of patients, and drafted the manuscript. ICC reviewed and amended the study protocol, contributed to enrolment of patients, interpreting data, and writing the final version of the manuscript. JBC reviewed and amended the study protocol, and contributed to interpreting data and writing the final version of the manuscript. MMRA conceived the trial, developed its initial protocol, analysed the data, jointly drafted and reviewed the final version of the manuscript, and is guarantor.
Funding: This study was supported by the Instituto de Medicina Integral Prof Fernando Figueira-IMIP (www.imip.org.br), a private, not for profit healthcare organisation based in Recife, Pernambuco, Brazil, where the study was carried out. The institute did not interfere with study design or analysis and the funding covered all study expenses, including purchase of the drug and placebo.
Competing interests: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: This study was approved by the Institutional Review Board (protocol 1029/2007). All the participants voluntarily agreed to take part in the trial and gave written informed consent.
Data sharing: Technical appendix, statistical code, and dataset available from the corresponding author at. Participants gave informed consent for data sharing.
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