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. 2023 Jan 10;2023(1):CD001955. doi: 10.1002/14651858.CD001955.pub5

Husby 1993.

Study characteristics
Methods Randomised, double‐blind controlled trial
Participants Study period: October 1990 to December 1991
Setting: Department of Paediatrics, Kolding Hospital, Denmark
Inclusion criteria: children admitted to hospital with croup (inspiratory stridor, cough, and respiratory distress) with a modified Westley croup score > 5 and informed parental consent
Exclusion criteria: clinical condition consistent with epiglottitis, foreign body aspiration, bronchiolitis, or asthma; received local or systemic steroid treatment or epinephrine
Baseline demographics (N = 36) (1 child excluded before placebo was administered):
  • proportion male: treatment: 80%; control: 75%

  • median (range) age in years: treatment: 1.6 (0.6 to 4.9); control: 1.1 (0.4 to 4.2)

  • median (range) modified Westley croup score: treatment: 8 (6 to 10); control: 8 (6 to 12)

Interventions Treatment (N = 20): 2, 1000 µg (2 mL 500 µg/mL) doses of nebulised budesonide, 30 minutes apart
Control (N = 16): 2, 2 mL doses of placebo (0.9% saline), 30 minutes apart
Both treatment and placebo were given with a dynamic flow rate of 8 L/min.
Outcomes Change in modified Westley croup score from baseline to 2 hours; use of antibiotics
Notes Funding source: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: insufficient information provided to permit a judgement
Allocation concealment (selection bias) Unclear risk Comment: insufficient information provided to permit a judgement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Comment: described as double‐blind, no further explanation. Insufficient information provided to permit a judgement.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Comment: no description of a third‐party outcome assessor. Carried over judgement from blinding of participants and personnel
Incomplete outcome data (attrition bias)
All outcomes Low risk Comment: 1 child omitted as did not receive treatment due to technical problems. No other missing outcome data
Selective reporting (reporting bias) Unclear risk Comment: no protocol identified. All prespecified outcomes in the methods appeared in the results.
Other bias Low risk Comment: no other sources of bias identified
Overall risk of bias
All outcomes Unclear risk Comment: at least 1 domain judged as unclear risk, and no domains judged as high risk