Caffeine for the Treatment of Apnea in Bronchiolitis: A Randomized Trial.

OBJECTIVE: To evaluate the efficacy and safety of caffeine citrate in the treatment of apnea in bronchiolitis. STUDY DESIGN: Eligible infants aged ≤4 months presenting to the main pediatric emergency service with apnea associated bronchiolitis were stratified by gestational age (<34 weeks or longer) and randomized to receive a single dose of intravenous 25 mg/kg caffeine citrate or saline placebo. The primary efficacy outcome was a 24-hour apnea-free period beginning after completion of the blinded study drug infusion. Secondary outcomes were frequency of apnea by 24, 48, and 72 hours after study medication, need for noninvasive/invasive ventilation, and length of stay in the hospital's pediatric intensive care/step-down unit. RESULTS: A total of 90 infants diagnosed with viral bronchiolitis associated with apnea (median age, 38 days) were enrolled. The rate of respiratory virus panel positivity was similar in the 2 groups (78% for the placebo group vs 84% for the caffeine group). The geometric mean duration to a 24-hour apnea-free period was 28.1 hours (95% CI, 25.6-32.3 hours) for the caffeine group and 29.1 hours (95% CI, 25.7-32.9 hours) for the placebo group (P = .88; OR, 0.99; 95% CI, 0.83-1.17). The frequency of apnea at 24 hours, 24-48 hours, and 48-72 hours after enrollment and the need for noninvasive and invasive ventilation were similar in the 2 groups. No safety issues were reported. CONCLUSIONS: A single dose of caffeine citrate did not significantly reduce apnea episodes associated with bronchiolitis. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01435486.

Nebulized magnesium for moderate and severe pediatric asthma: A randomized trial.

BACKGROUND: Intravenous magnesium sulfate, a rescue therapy added to bronchodilator and systemic steroid therapy for moderate and severe asthma, is uncommonly administered. We hypothesized that nebulized magnesium would confer benefit without undue risk. DESIGN AND METHODS: Patients aged 2 to 14 y with moderate and severe asthma (PRAM severity score ≥ 4) admitted to infirmary/observation unit care were randomized double-blind on admission to receive 800 mg nebulized magnesium or normal saline placebo after all received intensive therapy with combined nebulized albuterol-ipratropium and intravenous methylprednisolone. Time to medical readiness for discharge was the primary outcome; sample size was chosen to detect a 15% absolute improvement. Improvement over time in PRAM severity score and other secondary outcomes were compared for the overall group and severe asthma subset. RESULTS: One hundred and ninety-one magnesium sulfates and 174 placebo patients met criteria for analysis. The groups were similar with mean baseline PRAM scores >7. Blinded active therapy significantly increased blood magnesium level 2 hr post-treatment completion compared to placebo, 0.85 vs 0.82 mmol/L, P = 0.001. There were no important adverse effects. Accelerated failure time analysis showed a non-significantly shortened time to medical readiness for discharge of 14% favoring the magnesium sulfate group, OR = 1.14, 95% CI 0.93 to 1.40, P = 0.20. Mean times until readiness for discharge were 14.7 hr [SD 9.7] versus 15.6 hr [SD 11.3] for the investigational and placebo groups, respectively, P = 0.41. CONCLUSIONS: Adding nebulized magnesium to combined nebulized bronchodilator and systemic steroid therapy failed to significantly shorten time to discharge of pediatric patients with moderate or severe asthma.