A CONTROLLED TRIAL OF ANTEPARTUM GLUCOCORTICOID TREATMENT FOR PREVENTION OF THE RESPIRATORY DISTRESS SYNDROME IN PREMATURE INFANTS

TLDR

The trial evaluated whether betamethasone given to mothers at risk of preterm delivery before 37 weeks could reduce neonatal respiratory distress syndrome by accelerating fetal lung maturation. 282 mothers were randomized to betamethasone or placebo; 213 were in spontaneous labor, and when needed, ethanol or salbutamol were used to delay delivery while administering the study drug, achieving a 24‑hour delay in 77 % of cases. Betamethasone lowered early neonatal mortality from 15.0 % to 3.2 % and reduced RDS from 25.8 % to 9.0 % in infants under 32 weeks who received at least 24 h of treatment, with no deaths from hyaline membrane disease or intraventricular hemorrhage, though a possible rise in fetal death with severe hypertension was noted, warranting further trials.

Abstract

A controlled trial of betamethasone therapy was carried out in 282 mothers in whom premature delivery threatened or was planned before 37 weeks' gestation, in the hope of reducing the incidence of neonatal respiratory distress syndrome by accelerating functional maturation of the fetal lung. Two hundred and thirteen mothers were in spontaneous premature labor. When necessary, ethanol or salbutamol infusions were used to delay delivery while steroid or placebo therapy was given. Delay for at least 24 hours was achieved in 77% of the mothers. In these unplanned deliveries, early neonatal mortality was 3.2% in the treated group and 15.0% in the controls (p 0.01). There were no deaths with hyaline membrane disease or intraventricular cerebral hemorrhage in infants of mothers who had received betamethasone for at least 24 hours before delivery. The respiratory distress syndrome occurred less often in treated babies (9.0%) than in controls (25.8%, p 0.003), but the difference was confined to babies of under 32 weeks' gestation who had been treated for at least 24 hours before delivery (11.8% of the treated babies compared with 69.6% of the control babies p. 0.02). There may be an increased risk of fetal death in pregnancies complicated by severe hypertensionedema-proteinuria syndromes and treated with betamethasone, but no other hazard of steroid therapy was noted. We conclude that this preliminary evidence justifies further trials, but that further work is needed before any new routine procedure is established.