Antenatal betamethasone compared with dexamethasone (betacode trial): a randomized controlled trial.
OBJECTIVE
To compare betamethasone with dexamethasone in terms of effectiveness in reducing perinatal morbidities and mortality among preterm infants.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Elimian
Andrew
A
Department of Obstetrics, Gynecology and Reproductive Medicine, Stony Brook University, Stony Brook, New York, USA. andrew-elimian@ouhsc.edu
Garry
David
D
Figueroa
Reinaldo
R
Spitzer
Alan
A
Wiencek
Vandy
V
Quirk
J Gerald
JG
D000328:Adult; D001623:Betamethasone / Q000627:therapeutic use*; D002543:Cerebral Hemorrhage / Q000517:prevention & control*; D003907:Dexamethasone / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005315:Fetal Diseases / Q000517:prevention & control; D006801:Humans; D007231:Infant, Newborn; D009017:Morbidity; D011247:Pregnancy; D047928:Premature Birth / Q000188:drug therapy / Q000517:prevention & control*; D012127:Respiratory Distress Syndrome, Newborn / Q000517:prevention & control; D015149:Tocolytic Agents / Q000627:therapeutic use*
D015149:Tocolytic Agents; D003907:Dexamethasone; D001623:Betamethasone