TABLE 1

RCTs of Dexamethasone to Prevent or Treat BPD Reported Since 2001

Study, No. of CentersnEligibility Criteria (All on Mechanical Ventilation)Dexamethasone Dosing RegimenOutcome
McEvoy et al,17 1 center62500–1500 g BW; ≤32 wk gestation; 7–21 postnatal days5 mg/kg per d tapered over 7 d vs 0.2 mg/kg tapered over 7 dRate of survival without BPDa 76% vs 73% (NS); no benefit to higher dose
Odd et al,18 1 center33≤1250 g BW; 1–3 wk of age0.5 mg/kg per d tapered over 42 d vs “individualized” (same dose, shorter course)Rate of survival without BPD: 24% vs 30%(NS); no difference in 18-mo outcomes
Malloy et al,19 1 center16b<1501 g BW; <34 wk gestation; <28 postnatal days0.5 mg/kg per d tapered over 7 d vs 0.08 mg/kg per d for 7 dRate of survival without BPD: 11% vs 38%(NS); higher dose had more adverse effects, no apparent benefit
Walther et al,20 1 center36≥600 g BW; 24–32 wk gestation; 7–14 d postnatal age0.2 mg/kg per d tapered over 14 d vs placeboRate of survival without BPD: 65% vs 47% (NS); extubation: 76% vs 42%(P < .05)
Anttila et al,21 6 centers109b500–999 g BW; ≤31 wk gestation; eligible at 4 h of age0.25 mg/kg every 12 h × 4 doses vs placeboRate of survival without BPD: 58% vs 52%(NS)
Doyle et al,22 11 centers70b<1000 g BW; <28 wk gestation; >1 wk postnatal age0.15 mg/kg per d tapered over 10 d vs placeboRate of survival without BPD: 14% vs 9% (NS); extubation: 60% vs 12%(odds ratio: 11.2 [95% confidence interval: 3.2–39.0])
Rozycki et al,23 1 center61650–2000 g BW; ≥ 14 d postnatal age0.5 mg/kg per d tapered over 42 d vs inhaled beclomethasone at 3 different doses for 7 d followed by above-listed dexamethasone course, if still mechanically ventilatedRate of survival without BPD: 53% vs 46% (NS); extubation by 7 d: 7 of 15 vs 6 of 46(P < .01)
  • BW indicates birth weight; NS, not significant.

  • a BPD defined as receiving supplemental oxygen at 36 weeks postmenstrual age.

  • b Patient enrollment terminated early.