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. 2021 Oct 21;2021(10):CD001146. doi: 10.1002/14651858.CD001146.pub6

Sinkin 2000.

Study characteristics
Methods Multi‐centre randomised double‐blind trial
Participants 384 infants at < 30 weeks' gestation with RDS by clinical and radiographic signs, needing IPPV at 12 to 18 hours of age; had received at least 1 dose of surfactant
Interventions Dexamethasone 0.5 mg/kg at 12 to 18 hours of age, second dose 12 hours later
Control group given an equal volume of placebo
Outcomes Primary outcomes
  • Survival

    • Survival without oxygen at 28 days or 36 weeks

    • Survival without oxygen at 28 days or 36 weeks and without late corticosteroids

  • Length of time in oxygen, on ventilation, to regain birth weight, and in hospital

  • Hyperglycaemia

  • Hypertension

  • IVH

  • PDA

  • Sepsis

  • NEC

  • Isolated GI perforation

  • ROP

  • Air leak

  • Discharged home on oxygen

Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Random allocation in the pharmacy via labelled syringes. Stratification by centre. Exact method of randomisation not stated
Allocation concealment (selection bias) Low risk Allocation concealment: yes
Blinding of participants and personnel (performance bias)
All outcomes Low risk Blinding of intervention: yes
Blinding of outcome assessment (detection bias)
All outcomes Low risk Blinding of outcome measurement: yes
Incomplete outcome data (attrition bias)
All outcomes Low risk Complete follow‐up: yes
Selective reporting (reporting bias) Low risk All prespecified outcomes reported
Other bias Low risk None