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Randomized Controlled Trial Multicenter Study
A multicentre, randomised, double-blind, placebo-controlled trial of aminophylline for bronchiolitis in infants admitted to intensive care.
- Alastair Turner, Frank Shann, Carmel Delzoppo, Robert Henning, Anthony Slater, John Beca, Simon Erickson, and Warwick Butt.
- Royal Hospital for Sick Children, Glasgow, Scotland. frank.shann@rch.org.au.
- Crit Care Resusc. 2014 Sep 1;16(3):220-4.
ObjectiveTo determine whether aminophylline reduced the duration of respiratory support in children admitted to intensive care with bronchiolitis.DesignA multicentre, randomised, double-blind, placebo controlled trial.SettingPaediatric intensive care units in teaching hospitals.ParticipantsForty-five children with severe bronchiolitis.InterventionPatients were randomly assigned to receive an infusion of aminophylline (23) or placebo (22). The primary outcome measure was the number of hours of respiratory support required in the 120 hours after randomisation; respiratory support was defined as either nasal continuous positive airways pressure or mechanical ventilation.ResultsThe trial was stopped early due to poor recruitment. Respiratory support was required for a median of only 1.5 days (interquartile range [IQR], 0.4-3.5 days) in the aminophylline group compared with 1.9 days (IQR, 0.3-3.5) days in the placebo group. However, more patients in the placebo group were receiving respiratory support at the time of randomisation and, after adjustment for this, there was no suggestion of a beneficial effect of aminophylline among the small number of patients studied (P=0.54, exact log-rank test stratified by respiratory support at the time of randomisation and censored at the time of death in one child in the aminophylline group).ConclusionNot enough children were recruited for the study to test the hypothesis that aminophylline reduces the need for respiratory support in severe bronchiolitis. Consequently, the role of aminophylline in the management of severe bronchiolitis remains unknown.
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