Rosenfeld 1984.
| Study characteristics | ||
| Methods | Double‐blinded RCT | |
| Participants | 45 neonates admitted to NICU (Jewish Hospital Division, Interfaith Medical Center, New York, USA) between April 1981 and March 1983 with severe RDS. Inclusion requirements were ventilator dependent, with FiO2 > 0.7 at 24 hours of age to maintain PaO2 ≥ 50 torr. | |
| Interventions | Experimental: bovine SOD 0.25 mg/kg subcutaneously every 12 hours until no longer needing ventilator or CPAP and maintained on room air (n = 21). Control (Placebo): saline 0.25 mg/kg subcutaneously (n = 24). |
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| Outcomes | Mortality, severity of RDS, total days of oxygen therapy, days of mechanical ventilation at various rates, mean peak FiO2 and distribution of days at various oxygen concentrations, and mean peak inspiratory pressures during the first week were comparable in the 2 groups, duration of total CPAP, incidence of PDA, congestive heart failure need for indomethacin, incidence and severity of IVH, respiratory signs and clinical findings associated with BPD after discharge from NICU, radiological evidence of BPD, clinical problems associated with BPD, clinical diagnosis of BPD, pneumonia, hospitalization. | |
| Funding sources / declarations of interest | Funding and potential conflicts of interest not reported. | |
| Notes | This study had a small population size and was done in the pre‐surfactant era where the definition of bronchopulmonary dysplasia was different from what it is now. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Patients were assigned to SOD or placebo (saline diluent for SOD) groups according to previously constructed random selection charts. Patients were matched according to sex and birth weight (less than or equal to 1200 or greater than 1200 grams)". |
| Allocation concealment (selection bias) | Unclear risk | Not described in text |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind study. (Quote:) "Physicians caring for the patients were blind as to the medication being given". |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blind study. Additionally, (quote:) "Radiographs were taken at 3 and 12 months and were evaluated by a pediatric radiologist who was blind regarding therapy" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No patients lost to follow‐up. |
| Selective reporting (reporting bias) | Unclear risk | Protocol not available. |
| Other bias | Unclear risk | None. |
BPD = bronchopulmonary dysplasia; CPAP = continuous positive airway pressure; DSMC = data and safety monitoring committee; FiO2 = fraction of inspired oxygen; IVH = intraventricular hemorrhage; NEC = necrotizing enterocolitis; NICU = neonatal intensive care unit; PaO2 = partial pressure of oxygen; PDA = patent ductus arteriosus; PMA = postmenstrual age; PVL = proliferative verrucous leukoplakia; RCT = randomized controlled trial; RDS = respiratory distress syndrome; rhSOD = recombinant human superoxide dismutase; ROP = retinopathy of prematurity; SOD = superoxide dismutase; TA = tracheal aspirate.