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Dexamethasone in children mechanically ventilated for lower respiratory tract infection caused by respiratory syncytial virus: a randomized controlled trial. / van Woensel, Job B. M.; Vyas, Harish; AUTHOR GROUP.

In: Critical care medicine, Vol. 39, No. 7, 2011, p. 1779-1783.

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@article{fdb127b1f07c4bdeb1b485e4227caacc,
title = "Dexamethasone in children mechanically ventilated for lower respiratory tract infection caused by respiratory syncytial virus: a randomized controlled trial",
abstract = "To determine the efficacy of dexamethasone in the treatment of mechanically ventilated children with respiratory syncytial virus-severe lower respiratory tract infection. International, multicenter, randomized, double-blind, placebo-controlled trial. Twelve pediatric intensive care units. Children ( <2 yrs) mechanically ventilated for respiratory syncytial virus lower respiratory tract infection. Children were prestratified for severity of oxygen abnormalities on admission. Intravenous dexamethasone (0.6 mg/kg/day, 48 hrs) or placebo. A superiority approach was used in the subgroup of patients with mild oxygen abnormalities (arterial partial pressure of oxygen/fractional inspired oxygen concentration [PaO(2)/FIO(2)] >200 mm Hg and/or mean arterial pressure ≤10 cm H(2)O) and a noninferiority approach in those with severe oxygen abnormalities (PaO(2)/FIO(2) ≤200 mm Hg and mean arterial pressure >10 cm H(2)O). 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). 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",
author = "{van Woensel}, {Job B. M.} and Harish Vyas and {AUTHOR GROUP} and {de Neef}, M. and Merkus, {M. P.} and J. Ursum and {van der Lee}, {J. J. H.} and Kneyber, {M. C. J.} and {de Weerd}, W. and Duval, {E. L. I. M.} and {de Jaeger}, A. and F. Rosiers and {van Berlaer}, G. and D. Biarent and F. Otte and S. Baroncini and A. Conio and A. Sabra and M. Duthy and H. Pandya and S. Nadel and H. Betts",
year = "2011",
doi = "10.1097/CCM.0b013e318218a030",
language = "English",
volume = "39",
pages = "1779--1783",
journal = "Critical care medicine",
issn = "0090-3493",
publisher = "Lippincott Williams and Wilkins",
number = "7",

}

RIS

TY - JOUR

T1 - Dexamethasone in children mechanically ventilated for lower respiratory tract infection caused by respiratory syncytial virus: a randomized controlled trial

AU - van Woensel, Job B. M.

AU - Vyas, Harish

AU - AUTHOR GROUP

AU - de Neef, M.

AU - Merkus, M. P.

AU - Ursum, J.

AU - van der Lee, J. J. H.

AU - Kneyber, M. C. J.

AU - de Weerd, W.

AU - Duval, E. L. I. M.

AU - de Jaeger, A.

AU - Rosiers, F.

AU - van Berlaer, G.

AU - Biarent, D.

AU - Otte, F.

AU - Baroncini, S.

AU - Conio, A.

AU - Sabra, A.

AU - Duthy, M.

AU - Pandya, H.

AU - Nadel, S.

AU - Betts, H.

PY - 2011

Y1 - 2011

N2 - To determine the efficacy of dexamethasone in the treatment of mechanically ventilated children with respiratory syncytial virus-severe lower respiratory tract infection. International, multicenter, randomized, double-blind, placebo-controlled trial. Twelve pediatric intensive care units. Children ( <2 yrs) mechanically ventilated for respiratory syncytial virus lower respiratory tract infection. Children were prestratified for severity of oxygen abnormalities on admission. Intravenous dexamethasone (0.6 mg/kg/day, 48 hrs) or placebo. A superiority approach was used in the subgroup of patients with mild oxygen abnormalities (arterial partial pressure of oxygen/fractional inspired oxygen concentration [PaO(2)/FIO(2)] >200 mm Hg and/or mean arterial pressure ≤10 cm H(2)O) and a noninferiority approach in those with severe oxygen abnormalities (PaO(2)/FIO(2) ≤200 mm Hg and mean arterial pressure >10 cm H(2)O). 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). 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

AB - To determine the efficacy of dexamethasone in the treatment of mechanically ventilated children with respiratory syncytial virus-severe lower respiratory tract infection. International, multicenter, randomized, double-blind, placebo-controlled trial. Twelve pediatric intensive care units. Children ( <2 yrs) mechanically ventilated for respiratory syncytial virus lower respiratory tract infection. Children were prestratified for severity of oxygen abnormalities on admission. Intravenous dexamethasone (0.6 mg/kg/day, 48 hrs) or placebo. A superiority approach was used in the subgroup of patients with mild oxygen abnormalities (arterial partial pressure of oxygen/fractional inspired oxygen concentration [PaO(2)/FIO(2)] >200 mm Hg and/or mean arterial pressure ≤10 cm H(2)O) and a noninferiority approach in those with severe oxygen abnormalities (PaO(2)/FIO(2) ≤200 mm Hg and mean arterial pressure >10 cm H(2)O). 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). 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

U2 - 10.1097/CCM.0b013e318218a030

DO - 10.1097/CCM.0b013e318218a030

M3 - Article

C2 - 21460709

VL - 39

SP - 1779

EP - 1783

JO - Critical care medicine

JF - Critical care medicine

SN - 0090-3493

IS - 7

ER -

ID: 1406457