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. 2022 Apr 4;2022(4):CD010473. doi: 10.1002/14651858.CD010473.pub4

Lal 2018.

Study characteristics
Methods Study design: prospective, open‐label, randomised, single‐centre study
Study duration: November 2014 to March 2016
Participants Inclusion criteria
  • Setting: inpatient, single‐centre study

  • Country: India

  • Number: total 72; treatment group (36), control (36)

  • Age (mean (SD))

    • Treatment group: 4.0 (2.6) months

    • Control group: 4.7 (3.1) months

  • Sex (m/f)

    • Treatment group: 26/10

    • Control group: 28/8

  • Comorbidities: none


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.   
Interventions Treatment group
  • Intervention: bubble CPAP delivered in the children's ward with a Gregory circuit

  • Duration, frequency: for 1 hour, once only


Control group
  • Intervention: "standard care", which included maintenance of adequate hydration and oxygenation. Oxygen was delivered through mask or hood.

  • Duration, frequency: for 1 hour, once only

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.
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.
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