A MULTICENTER TRIAL OF 2 DEXAMETHASONE REGIMENS IN VENTILATOR-DEPENDENT PREMATURE-INFANTS

Background Ventilator-dependent premature infants are often treated wi th dexamethasone. However, the optimal timing of therapy is unknown. M ethods We compared the benefits and hazards of initiating dexamethason e therapy at two weeks of age and at four weeks of age in 371 ventilat or-dependent very-low-birth-weight infants (501 to 1500 g) who had res piratory-index scores (mean airway pressure x the fraction of inspired oxygen) of greater than or equal to 2.4 at two weeks of age. One hund red eighty-two infants received dexamethasone for two weeks followed b y placebo for two weeks, and 189 infants received placebo for two week s followed by either dexamethasone (those with a respiratory-index sco re of greater than or equal to 2.4 on treatment day 14) or additional placebo for two weeks. Dexamethasone was given at a dose of 0.25 mg pe r kilogram of body weight twice daily intravenously or orally for five days, and the dose was then tapered. Results The median time to venti lator independence was 36 days in the dexamethasone-placebo group and 37 days in the placebo-dexamethasone group. The incidences of chronic lung disease (defined as the need for oxygen supplementation at 36 wee ks' postconceptional age) were 66 percent and 67 percent, respectively . Dexamethasone was associated with an increased incidence of nosocomi al bacteremia (relative risk, 1.5; 95 percent confidence interval, 1.1 to 2.1) and hyperglycemia (relative risk, 1.9; 95 percent confidence interval, 1.2 to 3.0) in the dexamethasone-placebo group, elevated blo od pressure (relative risk, 2.9; 95 percent confidence interval, 1.2 t o 6.9) in the placebo-dexamethasone group, and diminished weight gain and head growth (P<0.001) in both groups. Conclusions Treatment of ven tilator-dependent premature infants with dexamethasone at two weeks of age is more hazardous and no more beneficial than treatment at four w eeks of age. (C) 1998, Massachusetts Medical Society.