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Randomized Controlled Trial
. 2016 Oct:177:204-211.e3.
doi: 10.1016/j.jpeds.2016.04.060. Epub 2016 May 14.

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

Affiliations
Randomized Controlled Trial

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

Khalid Alansari et al. J Pediatr. 2016 Oct.

Abstract

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.

Keywords: apnea; bronchiolitis; caffeine citrate; respiratory syncytial virus.

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Figures

Figure 2
Figure 2
Time from the end of study drug infusion to a 24-hour apnea-free period. Accelerated failure time analysis shows a geometric mean time for the caffeine group 28.7 hours (95% CI, 25.6-32.3 hours) and 29.1 hours (95% CI, 25.7-32.9 hours) for the placebo group (OR, 0.99; 95% CI, 0.83-1.17; P = .88).
Figure 1
Figure 1
Study flow chart of infants presenting with bronchiolitis and apnea.
Figure 3
Figure 3
Number of new apnea episodes after blinded treatment. A, First 24 hours. B, 24-48 hours. C, 48-72 hours.
Figure 4
Figure 4
Number of new apnea episodes after blinded treatment in infants of corrected age ≤28 days. A, First 24 hours. B, 24-48 hours. C, 48-72 hours.

Comment in

References

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