Antenatal betamethasone compared with dexamethasone (betacode trial): a randomized controlled trial. Antenatal corticosteroid therapy and fetal behaviour: a randomised study of the effects of betamethasone and dexamethasone. Antenatal corticosteroid therapy: a comparative study of dexamethasone and betamethasone effects on fetal Doppler flow velocity waveforms. Single vs weekly courses of antenatal corticosteroids for women at risk of preterm delivery: A randomized controlled trial. Corticosteroid therapy for prevention of respiratory distress syndrome in severe preeclampsia. A randomized, controlled trial of oral and intramuscular dexamethasone in the prevention of neonatal respiratory distress syndrome. Efficacy of sequential early systemic and inhaled corticosteroid therapy in the prevention of chronic lung disease of prematurity. Randomized controlled trial of three different doses of aerosol beclomethasone versus systemic dexamethasone to promote extubation in ventilated premature infants. Effect of antenatal dexamethasone administration on the prevention of respiratory distress syndrome.
To compare betamethasone with dexamethasone in terms of effectiveness in reducing perinatal morbidities and mortality among preterm infants.
                We enrolled 299 women at risk for preterm delivery in a double-blind, placebo-controlled, randomized trial of antenatal betamethasone compared with dexamethasone at Stony Brook University Hospital from August 2002 through July 2004. We excluded women with clinical chorioamnionitis, fetal structural and chromosomal abnormalities, prior antenatal steroid exposure, and steroid use for other indications. Statistical analysis was performed in accordance of the intention-to-treat principle.
                There were no significant differences between the groups with regard to baseline characteristics. The rate of respiratory distress syndrome, need for vasopressor therapy, necrotizing enterocolitis, retinopathy of prematurity, patent ductus arteriosus, neonatal sepsis, and neonatal mortality were not significant different between the groups. However, the rates of intraventricular hemorrhage (6 of 105 [5.7%] compared with 17 of 100 [17.0%], relative risk [RR] 2.97, 95% confidence interval [CI] 1.22-7.24, P=.02) and any brain lesion (7 of 105 [6.7%] compared with 18 of 100 [18.0%], RR 2.7, 95% CI 1.18-6.19, P=.02) were significantly lower in neonates exposed to dexamethasone compared with betamethasone. The absolute risk reduction in the rate of intraventricular hemorrhage was 11.3 % ( 95% CI 2.7-11.9%), and the number needed to treat was 9 (95% CI 5-37) in favor of dexamethasone.
                Betamethasone and dexamethasone are comparable in reducing the rate of most major neonatal morbidities and mortality in preterm neonates. However, dexamethasone seems to be more effective in reducing the rate of intraventricular hemorrhage compared with betamethasone. To compare the effects of maternal betamethasone and dexamethasone administration on fetal behaviour and fetal heart rate variation.
                A prospective randomised study of 60 women at increased risk of preterm delivery.
                Fetal heart rate and its variation, the incidence of fetal body and breathing movements.
                Obstetric unit, University Hospital, Utrecht, The Netherlands.
                Following maternal betamethasone administration (day 2), fetal heart rate variation was reduced by 19% and fetal body and breathing movements by 49% and 85%, respectively. After dexamethasone treatment there was a significant increase in short term fetal heart rate variation (24%) on day 1. All values returned to baseline on day 4, indicating that no fetal deterioration had occurred during the course of the study period.
                Betamethasone, with probably the greater beneficial effect, has more effects on fetal behaviour and fetal heart rate variation than dexamethasone. When assessing fetal condition, due account needs to be taken of these effects. To compare the effects of antenatal administration of dexamethasone and betamethasone, used in two different regimens, on fetal Doppler flow velocities.
                Sixty-seven women at risk for preterm delivery received course of corticosteroids by means of a computer-generated randomization table. The Doppler examination of the pulsatility index (PI) of the umbilical artery (UA), the middle cerebral artery (MCA) and the middle cerebral artery/umbilical artery PI ratio (MCA PI/UA PI) were performed before treatment, 24 and 72 h after the first dose of corticosteroids. The SAS system was used to perform statistical analysis.
                No significant change was observed in UA PI through dexamethasone therapy. In MCA there was a significant decrease in PI at 72 h (2+/-0.43 before and 1.68+/-0.31 after, p=0.0001). Similarly a significant decrease in MCA PI/UA PI ratio was noted (2.09+/-0.51 before and 1.83+/-0.4 after, p=0.0137). No significant changes were observed in UA PI, MCA PI and MCA PI/UA PI ratio during betamethasone treatment.
                Our results indicate significant decrease in fetal middle cerebral artery impedance at 72 h after maternal administration of the first dose of dexamethasone. Effects of dexamethasone on fetal brain warrants further research. The practice of administering weekly courses of antenatal corticosteroids to pregnant women at risk of preterm delivery is widespread, but no randomized trial has established the efficacy or safety of this practice.
                To evaluate the efficacy of weekly administration of antenatal corticosteroids compared with a single course in reducing the incidence of neonatal morbidity and to evaluate potential complications of weekly treatment.
                Randomized, double-blind, placebo-controlled intention-to-treat trial conducted in 13 academic centers in the United States from February 1996 through April 2000.
                A total of 502 pregnant women between 24 and 32 completed weeks' gestation who were at high risk of preterm delivery.
                All patients received a complete single course of antenatal corticosteroids (either betamethasone, 12 mg intramuscularly repeated once in 24 hours for 2 doses, or dexamethasone, 6 mg intramuscularly repeated every 12 hours for 4 doses). Participants who had not delivered 1 week after receipt of the single course were randomly assigned to receive either betamethasone, 12 mg intramuscularly repeated once in 24 hours for 2 doses every week until 34 weeks' gestation or delivery, whichever came first (n = 256), or a similarly administered placebo (n = 246).
                Composite neonatal morbidity (including severe respiratory distress syndrome, bronchopulmonary dysplasia, severe intraventricular hemorrhage, periventricular leukomalacia, proven sepsis, necrotizing enterocolitis, or perinatal death).
                Composite morbidity occurred in 22.5% of the weekly-course group vs 28.0% of the single-course group (unadjusted relative risk, 0.80; 95% confidence interval, 0.59-1.10). Neither group assignment nor the number of treatment courses was associated with a reduction in composite morbidity.
                Weekly courses of antenatal corticosteroids did not reduce composite neonatal morbidity compared with a single course of treatment. Weekly courses of antenatal corticosteroids should not be routinely prescribed for women at risk of preterm delivery. The objective of the study was to determine the efficacy and side effects of corticosteroid therapy for pregnant women with severe preeclampsia in the prevention of respiratory distress syndrome in their premature neonates.
                A prospective double-blind randomized trial enrolled 218 pregnant women with severe preeclampsia and gestational age between 26 and 34 weeks. One hundred ten received betamethasone (12 mg administered intramuscularly, repeated after 24 hours and then once a week) and 108 received placebo. Relative risks and 95% confidence intervals of respiratory distress syndrome and other neonatal and maternal complications were calculated for corticosteroid use.
                Frequency of respiratory distress syndrome was significantly reduced in the corticosteroid group (23%) with respect to the placebo group (43%), with a relative risk of 0.53 (95% confidence interval 0.35-0. 82). Relative risks of intraventricular hemorrhage, patent ductus arteriosus, and perinatal infection were significantly decreased in the corticosteroid group: 0.35 (95% confidence interval 0.15-0.86), 0.27 (95% confidence interval 0.08-0.95), and 0.39 (95% confidence interval 0.39-0.97), respectively. There was no significant difference in the frequency of stillbirth, but the neonatal mortality rate was lower in the corticosteroid group (14%) than in the placebo group (28%), with a relative risk of 0.5 (95% confidence interval 0.28-0.89). There was increased risk of gestational diabetes but of no other maternal complication after corticosteroid therapy, and mean blood pressures were similar in the 2 groups.
                Antenatal corticosteroid therapy with betamethasone for acceleration of fetal lung maturity is a safe and efficient treatment in patients with severe preeclampsia at between 26 and 34 weeks' gestation. The study's objective was to compare the efficacies of oral and intramuscular antenatal administration of dexamethasone in reducing neonatal respiratory distress syndrome.
                Subjects at high risk for preterm delivery between 24 and 33 weeks' gestation were prospectively randomly assigned to receive either 6 mg intramuscular dexamethasone or 8 mg oral dexamethasone every 12 hours for 4 doses. The regimen was repeated weekly until 34 weeks' gestation if delivery had not yet occurred. A blinded data review was performed. The primary outcome of the trial was respiratory distress syndrome. Data were analyzed in an intent to treat fashion. Comparisons were made with an unpaired t test, chi2 or Fisher exact test, and survival analysis. P <.05 was considered significant.
                The study was discontinued at 39% enrollment after a blinded review of available outcomes. A total of 170 women with 188 fetuses were randomly assigned. The oral and intramuscular groups had similar mean gestational ages at enrollment (29.9 weeks vs 29.2 weeks) and similar median latencies (9.5 vs 10 days). No difference in the frequency of respiratory distress syndrome was found between the oral and intramuscular groups, (34.3% vs 29.8%). Neonatal sepsis (10.1% vs 1.2%, P =.01) and intraventricular hemorrhage (10.1% vs 2. 4%, P =.04) were significantly higher in the oral group. There were no statistical differences in the frequencies of necrotizing enterocolitis or neonatal death. A subgroup analysis of 112 patients who were delivered at <34 weeks' gestation revealed no statistical difference in respiratory distress syndrome between the groups; however, oral dexamethasone was associated with a significant increase in sepsis (15.9% vs 1.6%, P =.009) and intraventricular hemorrhage (15.9% vs 3.3%, P =.03).
                Oral administration increases neonatal morbidity without demonstrable benefit and should not at this time be used clinically for induction of fetal pulmonary maturation. In order to assess the efficacy of a combination of systemic and nebulized corticosteroids in reducing the incidence and severity of chronic lung disease (CLD) in very low birthweight (VLBW) infants, 60 ventilator-dependent infants < or = 1500 g were randomly assigned to receive either steroids or placebo as of 7 d. The steroid group (n = 30, GA = 25.8 +/- 1.6 weeks, BW = 731 +/- 147 g) received systemic dexamethasone for 3 d, followed by nebulized budesonide for 18 d. Control infants (n = 30, GA = 25.9 +/- 1.8 weeks, BW = 796 +/- 199 g) received systemic and inhaled saline. Steroid-treated infants required less ventilatory support between 9 and 17 d (p < 0.01), and had greater lung compliance at 10 d (p = 0.01), but not subsequently. CLD incidence at 36 weeks was 45.5% vs 56.0% in controls, and fewer steroid-treated infants required dexamethasone rescue (23.3% vs 56.7%, p = 0.017). Survival to discharge was similar (73.3% vs 83.3%), as were the durations of mechanical ventilation, supplemental oxygen use, and hospitalization. Tracheal effluent elastase/albumin ratios and serum cortisol values did not differ between groups, and no adverse effects were noted. We conclude that early dexamethasone administration was associated with improved pulmonary function, which was not sustained with nebulized budesonide. However, the steroid regimen studied reduced the need for dexamethasone rescue in infants with CLD. Our objective was to determine the safety and efficacy of aerosol beclomethasone vs. systemic dexamethasone for extubation in premature infants at high risk for chronic lung disease (CLD). Intubated preterm infants who were identified as being at high risk for moderate-severe CLD on day 14 of life were randomized to one of four groups. The control group received systemic dexamethasone and aerosol placebo, while the other three groups received either high (2.40-3.69 microg/kg/day delivered to lungs), medium (1.0-1.85 microg/kg/day), or low (0.48-0.74 microg/kg/day) dose aerosol beclomethasone and systemic placebo. Those receiving aerosol steroids who remained ventilator-dependent after 7 days were switched to standard 42-day tapering doses of systemic dexamethasone. The primary outcome was extubation within 1 week of starting steroids, using predefined criteria. Secondary variables included changes in lung function, rates of side effects, and tracheal aspirate white blood cell counts. Sixty-one infants with birth weights of 761 +/- 18 g (mean +/- SEM) and gestational ages of 25.7 +/- 0.2 weeks were randomized to one of the four groups. Seven of 15 infants in the control systemic dexamethasone group were successfully extubated compared with 3/16 in the high-dose beclomethasone group, 1/15 in the medium-dose group, and 2/15 in the low-dose group (P < 0.01). Only dexamethasone subjects demonstrated improvements in lung function over the study period. These infants also had significant increases in blood pressure and blood glucose levels, as well as a decline in their tracheal aspirate white blood cell count. In conclusion, aerosol beclomethasone at the very low doses used in this study did not facilitate extubation in intubated premature infants at high risk for moderate-severe CLD.
                Copyright 2003 Wiley-Liss, Inc. A double-blind, collaborative, randomized trial was initiated in 1976 to evaluate dexamethasone administered to mothers as a method of preventing neonatal respiratory distress syndrome (RDS). Five centers enrolled 696 women at risk for premature delivery. Up to 20 mg of dexamethasone phosphate (5 mg every 12 hours) or a placebo was administered intramuscularly. The overall incidence of RDS was different between control subjects (18.0%) and steroid-treating mothers (12.6%) (P less than 0.05). The effect was, however, mainly attributable to discernible differences among singleton female infants (P less than 0.001), whereas no treatment effect was observed in male infants (P = 0.96). Non-Caucasians were improved whereas Caucasians showed little benefit. Fetal and neonatal mortality and maternal postpartum infection rates were not different. Neurologic examination at 40 weeks' gestation demonstrated no significant difference in the rate of abnormal outcomes in the neonatal steroid group (P = 0.2).
Dexamethasone may have some benefits compared with betamethasone such as less intraventricular haemorrhage, although perhaps a higher rate of NICU admission (seen in only one trial). Apart from a suggestion from another small trial that the intramuscular route may have advantages over an oral route for dexamethasone, few other conclusions about optimal antenatal corticosteroid regimens were able to be made. Trials of commonly used corticosteroids are most urgently needed, followed by trials of dosages and other variations in regimens.