Methods |
Blinding of randomization: Yes
Blinding of intervention: Yes
Complete follow‐up: Yes
Blinding of outcome measurement: Yes only for assessment of chest radiographs and cranial ultrasounds. |
Participants |
Preterm infants with birth weight 700 to 1300 grams, less than 24 hours old, intubated and on mechanical ventilation for treatment of respiratory distress syndrome. Had received surfactant within first 24 hours of life. |
Interventions |
Experimental group 1:
Superoxide dismutase 2.5 mg/kg (n=11)
Experimental group 2: Superoxide dismutase 5 mg/kg (n=11)
In both these groups the drug was given intratracheally, repeated every 48 hours until extubated or until 7 doses completed, whichever was earlier.
Control group:
Equal volume of saline intratracheally, repeated every 48 hours until extubated or until 7 doses completed, whichever was earlier (n=11). |
Outcomes |
Oxygen dependency with abnormal chest radiograph at 28 days, oxygen dependency at 36 weeks postconceptual age, intraventricular hemorrhage all grades, intraventricular hemorrhage, grades 3 and 4, patent ductus arteriosus, retinopathy of prematurity, necrotizing enterocolitis, sepsis, mortality at 28 days, overall mortality. |
Notes |
Small sample size. In this review we combined the data from patients from both dosage regimens as no dose‐response relationship was evident in the results. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Low risk |
A ‐ Adequate |