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

Shinwell 1996.

Study characteristics
Methods Multi‐centre double‐blind randomised controlled trial
Participants Inclusion: 248 preterm infants with birth weight 500 grams to 2000 grams, 1 to 3 days old, requiring mechanical ventilation with > 40% oxygen
Exclusions: active bleeding, hypertension, hyperglycaemia, active infection, lethal congenital anomaly
Interventions Intravenous dexamethasone 0.25 mg/kg every 12 hours 6 times
Controls given saline placebo
Outcomes
  • Mortality

  • Survival with no O₂

  • Mechanical ventilation at 3 and 7 days

  • BPD

  • Duration in hospital

  • IVH

  • PVL

  • Pneumothorax

  • PIE

  • PDA

  • Sepsis

  • Hypertension

  • Hyperglycaemia

Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random allocation, stratified by centre and birth weight, from random numbers list in the pharmacy
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 for short‐term; 84% for long‐term
Selective reporting (reporting bias) Low risk All prespecified outcomes reported
Other bias Low risk None