Lal 2018.
Study characteristics | ||
Methods | Study design: prospective, open‐label, randomised, single‐centre study Study duration: November 2014 to March 2016 |
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Participants |
Inclusion criteria
Study enrolment criteria: 72 children hospitalised with clinical diagnosis of acute bronchiolitis were eligible for inclusion in the study. Bronchiolitis was defined as respiratory distress (respiratory rate ≥ 50/min) in an infant aged from 1 month to 1 year, along with wheezing on auscultation and hyperinflated lung. Exclusion criteria: infants who were in imminent need of ventilator support were excluded. |
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Interventions |
Treatment group
Control group
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Outcomes |
Primary outcomes: change in respiratory rate after the first hour of treatment Secondary outcomes: change in Silverman‐Anderson score, and a Modified Paediatric Society of New Zealand Severity Score (MPSNZ‐SS): before starting treatment, and at 1 hour following the start of treatment Need for mechanical ventilation was reported. Time to recovery was not reported. |
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Notes | Funding source: no funding received Contact with study authors for additional information: yes. However, no additional information was provided. Other: conflict of interest stated as none. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation in blocks of 8 using computer software |
Allocation concealment (selection bias) | Low risk | Allocation done using sequentially numbered, opaque, sealed envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label study |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcome assessors were not blinded to the intervention. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 child in the control arm (who needed mechanical ventilation) and 4 children in the intervention arm (2 who needed mechanical ventilation and 2 who did not tolerate CPAP) did not complete the study. Intention‐to‐treat analysis conducted. |
Selective reporting (reporting bias) | Low risk | All outcomes mentioned in study were reported. |
Other bias | Low risk | Funding: declared by authors as none Competing interests: declared by authors as none |