Chidini G, Piastra M, Marchesi T, et al. Continuous positive airway pressure with helmet versus mask in infants with bronchiolitis: an RCT. Pediatrics 2015;135:e868–75.
Multicenter, nonblinded, randomized controlled trial.
Included: Children (6–12 months old) with a diagnosis of RSV infection consistent with clinical features, positive nasopharyngeal swabs, and predefined acute respiratory failure admitted to 3 Italian pediatric intensive care units.
Excluded: Need for intubation; Glasgow Coma Scale score < 12; acidosis (pH < 7.25); cough or gag reflex impairment; upper airway obstruction; facial/gastric surgery; need for vasopressor or inotropes; enrollment in another study.
Helmet CPAP in increasing from 4–10 cm H2O (by 2 cm H2O) to obtain pulse oxygen saturation ≥ 94% with fraction of inspired oxygen ≤ 0.6 continuously for 24 hours until oxygenation and clinical status improved.
Face mask CPAP same as above.
Primary: Treatment failure defined as discontinuation of CPAP because of intolerance of or need for intubation. Intolerance was assessed using the Objective Pain Scale (OPS) and the COMFORT scale.
Secondary: CPAP application time; number of patients requiring sedation; and complications.
N = 30 patients.
|Sig.||Outcome||Outcome Helmet/Total vs. Outcome Face Mask/Total||NNT (95% CI)|
|NSS||Treatment failure||3/17 vs. 7/13||2.8 (1.5 to ∞)|
|SS||Requiring sedation||6/17 vs. 13/13||1.7 (1.5 to 4.6)|
|NSS||Complications||0/17 vs. 0/17||N/A|
CI = confidence interval; N/A = not available; NNT = number needed to treat; NSS = not statistically significant; Sig. = significance; SS = statistically significant.
Risk of Bias Assessment
|1||The patients were recruited consecutively.||Yes||Yes||Yes|
|2||The patients were adequately randomized (allocation sequence adequately generated).||Yes||Yes||Yes|
|3||The allocation sequence was adequately concealed.||Yes||Yes||Yes|
|4||The patients in all groups were similar with respect to prognostic factors.||Yes||Yes||Yes|
|5||All clinicians, patients, and outcome assessors were unaware of group allocation.||No||No||No|
|6||All groups were treated equally except for the intervention.||Yes||Yes||Yes|
|7||The follow-up was complete given the study duration (100% if in-hospital follow-up).||Yes||Yes||Yes|
|8||The patients were analyzed in the groups to which they were randomized (ITT).||Yes||Yes||Yes|
|9||All patient-important outcomes were considered.||No||No||No|
|10||The effect size of the primary outcome is clinically significant.||No||No||No|
Funding & Conflicts of Interest
No external funding.
Conflicts of Interest
Potential Threats to Validity
Type I error due to small sample size secondary to early trial termination.
No time specification for outcomes. Tools to assess intolerance to CPAP may not be ideal. The OPS assesses crying as an item, but it is not clear how this was assessed during CPAP application or if the infant was sedated. Similarly, the OPS assesses complaints of pain, but the participants are preverbal. Behavioural measures of distress may have been more appropriate
Sample size requirement was 30 per group, but the study was stopped following an interim analysis because it was believed that the primary end point was achieved in favor of helmet treatment.
Worster A; Poonai N; Chan M.
Competing Interest Disclosure
Dr. Chan - No conflicts of interest (ICMJE)
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