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

Subhedar 1997.

Study characteristics
Methods Randomised controlled trial ‐ factorial design
Participants Inclusion: 42 preterm infants, entry at 96 hours if gestation < 32 weeks, mechanical ventilation from birth, surfactant treatment, high risk of developing BPD based on score (Ryan 1996)
Exclusions: major congenital anomaly, structural cardiac defect, significant ductus shunting, culture‐positive sepsis, IVH with parenchymal involvement, pulmonary or GI haemorrhage, abnormal coagulation, thrombocytopenia (platelets < 50,000)
Interventions Intravenous dexamethasone at 12‐hourly intervals for 6 days, 0.5 mg/kg/dose for 6 doses, and 0.25 mg/kg/dose for a further 6 doses. Inhaled NO 5 to 20 ppm for 72 hours
Control groups were not given placebo
Outcomes
  • Mortality

  • BPD at 28 days and > 36 weeks with abnormal chest radiograph

  • Duration of ventilation

  • Time to extubation

  • Duration of hospitalisation

  • Maximum grade of IVH

  • Pulmonary haemorrhage

  • Pneumothorax

  • Severe PDA

  • NEC

  • ROP (stage 3 or 4)

  • Complications including ileal perforation, upper GI haemorrhage, hyperglycaemia, hypertension, septicaemia

Notes Note factorial design, which means that half of treated infants and half of control infants also received 72 hours of inhaled NO
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random allocation by computer‐generated random numbers and sealed envelopes. Factorial design provided 4 groups: early dexamethasone, inhaled NO, both drugs together, and neither drug
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) Unclear risk All prespecified outcomes reported
Other bias Low risk None