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

Romagnoli 1999.

Study characteristics
Methods Randomised non‐blinded controlled trial
Participants 50 infants < 1251 grams or < 33 weeks, oxygen‐dependent at 72 hours, at high risk of BPD according to a scoring system predicting 90% risk of BPD
Interventions Dexamethasone 0.5 mg/kg/d for 3 days, 0.25 mg/kg/d for 3 days, and 0.125 mg/kg/d for 1 day
Control group: no mention of placebo
Outcomes
  • Survival to 28 days

  • Survival to discharge

  • PDA

  • IVH (grades 3 and 4)

  • PVL

  • Sepsis

  • NEC

  • ROP (stages III and above)

  • Requiring ventilation at 28 days

  • BPD at 28 days and 36 weeks

  • Hyperglycaemia

  • Hypertension

  • Needed late corticosteroids

  • Growth failure

  • Left ventricular hypertrophy

Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random allocation via random numbers, concealed in numbered sealed envelopes
Allocation concealment (selection bias) Low risk Allocation concealment: yes
Blinding of participants and personnel (performance bias)
All outcomes High risk Blinding of intervention: no
Blinding of outcome assessment (detection bias)
All outcomes High risk Blinding of outcome measurements: no
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