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

Garland 1999.

Study characteristics
Methods Multi‐centre placebo‐controlled randomised trial
Participants 241 infants weighing between 500 grams and 1500 grams, who received surfactant, at significant risk for BPD or mortality based on a model used to predict at 24 hours
Interventions 3‐day course of dexamethasone beginning at 24 to 48 hours. First 2 doses were 0.4 mg/kg, third and fourth doses 0.2 mg/kg, and fifth and sixth doses 0.1 mg/kg and 0.05 mg/kg, respectively. Dexamethasone dose was reduced slightly after first interim analysis (see Notes)
Similar volume of normal saline was given to control infants
Outcomes Primary outcomes
  • Survival without BPD defined as oxygen therapy at 36 weeks to maintain SaO₂ > 91%

  • Mortality


Secondary outcomes
  • Duration of ventilation and supplemental oxygen

  • Respiratory support at 28 days of life

  • Length of stay for survivors

  • Use of subsequent dexamethasone therapy

  • Usual complications of prematurity

Notes At first interim analysis (n = 75), increased risk of GI perforation was noted in the dexamethasone group. Data Monitoring Committee recommended reducing the dexamethasone dose to 4 doses of 0.25 mg/kg/dose every 12 hours begun at 24 to 48 hours, followed by doses of 0.125 mg/kg and 0.05 mg/kg at the next two 12‐hour periods, respectively
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation by study pharmacists at each centre
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 measurements: 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