Skip to main content
. 2023 Jan 10;2023(1):CD001955. doi: 10.1002/14651858.CD001955.pub5

Leipzig 1979.

Study characteristics
Methods Randomised, double‐blind controlled trial
Participants Study period: November 1976 to March 1978
Setting: Pediatric Service of the State University Hospital or the Crouse‐Irving Memorial Hospital, Syracuse, NY, USA
Inclusion criteria: all children admitted to hospital with a diagnosis of croup with disease of sufficient severity on a predetermined scoring system; consent of the child's physician and parents
Exclusion criteria: not reported
Baseline demographics (N = 30):
  • proportion males: not reported

  • mean age in months: treatment: 21.3; control: 21.0

  • mean (SD) croup score: treatment: 8.46 (1.45); control: 8.14 (1.46)

Interventions Treatment (N = 16): 2, 0.30 mg/kg doses of intramuscular dexamethasone (4 mg/mL)
Control (N = 14): 2 doses of intramuscular placebo (sterile saline) (1 dose initially and another 2 hours later)
Outcomes Change in croup score from baseline to 24 hours; length of stay at hospital; intubation
Notes Funding source: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "assigned from a table of random numbers"
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 Quote: "Vials had been previously prepared containing either dexamethasone (4 mg/L) or sterile saline. They were marked only with a number, assigned from a table of random numbers"
Comment: described as double‐blind. Unclear who was blinded and who prepared the vials. Subjective outcomes
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Quote: "Vials had been previously prepared containing either dexamethasone (4 mg/L) or sterile saline. They were marked only with a number, assigned from a table of random numbers"
Comment: described as double‐blind. Unclear who was blinded and who prepared the vials. Subjective outcomes
Incomplete outcome data (attrition bias)
All outcomes Low risk Comment: no 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