Objective: To determine the efficacy of dexamethasone in the treatment of mechanically ventilated children with respiratory syncytial virus–severe lower respiratory tract infection.
Design: International, multicenter, randomized, double-blind, placebo-controlled trial.
Setting: Twelve pediatric intensive care units.
Subjects: Children (<2 yrs) mechanically ventilated for respiratory syncytial virus lower respiratory tract infection. Children were prestratified for severity of oxygen abnormalities on admission.
Intervention: Intravenous dexamethasone (0.6 mg/kg/day, 48 hrs) or placebo.
Measurements and Main Results: A superiority approach was used in the subgroup of patients with mild oxygen abnormalities (arterial partial pressure of oxygen/fractional inspired oxygen concentration [PaO2/Fio2] >200 mm Hg and/or mean arterial pressure ≤10 cm H2O) and a noninferiority approach in those with severe oxygen abnormalities (PaO2/Fio2 ≤200 mm Hg and mean arterial pressure >10 cm H2O). Primary outcome was the duration of mechanical ventilation. In the subgroup with mild oxygenation abnormalities, 45 of the 89 included patients received dexamethasone and 44 placebo; in the subgroup with severe oxygenation abnormalities, 28 of the 56 included patients received dexamethasone and 28 placebo. Baseline characteristics in both treatment arms were similar for both subgroups. After the third interim analysis, the trial was stopped early for futility taking the slow enrollment into account. At that time, the median duration (interquartile range) of mechanical ventilation was 137 (91–195) hrs in the dexamethasone- and 139 (117–188) hrs in the placebo-treated patients in the subgroup with mild oxygenation abnormalities (p = .6). In the subgroup with severe oxygenation abnormalities, it was 171 (136–212) hrs in the dexamethasone- and 170 (125–201) hrs in the placebo-treated patients (p = .6).
Conclusion: In this prematurely ended trial in children mechanically ventilated for severe respiratory syncytial virus–lower respiratory tract infection, we found no evidence of a beneficial effect of dexamethasone in children with mild oxygenation abnormalities. Neither was evidence found that dexamethasone may prolong mechanical ventilation in those with severe oxygenation abnormalities.
From the Emma Children's Hospital/Academic Medical Center (JBMvW), Amsterdam, The Netherlands; and the Nottingham University Hospital (HV), Nottingham, UK.
This trial has been made possible by financial support from the Maarten Kapelle Foundation, the van Reekum van Moorselaar Foundation, the Johannes Foundation, and the Christine Bader Foundation.
Currently Controlled Trials no. ISRCTN 13421709.
STAR Trial Group: M. de Neef, D. Blom (currently Zaans Medical Center, Zaandam, The Netherlands), M. P. Merkus, J. Ursum J, J. H. van der Lee (Academic Medical Center, Amsterdam, The Netherlands), M. C. J. Kneyber (VU University Medical Center, Amsterdam The Netherlands; currently University Medical Center Groningen/Beatrix Children's Hospital Groningen, The Netherlands), W. de Weerd (University Hospital Groningen/Beatrix Children's Hospital Groningen, The Netherlands); E. L. I. M. Duval (Queen Paola Children's Hospital, Antwerp, Belgium), A. de Jaeger, F. Rosiers (University Hospital, Ghent, Belgium), G. van Berlaer (University Hospital Brussels, Belgium), D. Biarent, F. Otte (Queen Fabiola Children's University Hospital, Brussels, Belgium), S. Baroncini (Sant Orsola-Malpighi University Hospital, Bologna, Italy), A. Conio (Children's Hospital Regina Margherita, Torino, Italy), A. Sabra (Nottingham University Hospital, Nottingham, UK; currently University Hospitals Bristol NHS Foundation Trust, UK), M. Duthy, H. Pandya (Leicester Royal Infirmary, Leicester, UK), S. Nadel, and H. Betts (St Mary's Hospital, London, UK).
The authors have not disclosed any potential conflicts of interest.
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