Dose:    Not established

Frequency: Not established

Comments: Recombinant superoxide dismutase ( rhSOD ) is an antioxidant delivered by tracheal instillation. Recent research suggests that the inflammatory changes that predispose infants to subsequent bronchopulmonary dysplasia may occur as early as 12 hours of age. Since antioxidants are decreased in premature infants, current investigations are evaluating different antioxidants as part of early therapy for intubated infants. Recombinant human superoxide dismutase is currently undergoing evaluation to reduce lung inflammation during the first day of life that can serve as a marker for lung injury. Rosenfeld (Pediatr 1996; 97:811) reported the results of a Phase 1 study of 26 preterm infants, with birth weights of 750 to 1250 grams and were intubated for HMD, who received a single dose of rhSOD or placebo on the first day of life. Seven infants received a high dose of rhSOD (5 mg/kg); eight infants received a low dose of rhSOD (0.5 mg/kg); the remaining 11 infants received a placebo. The study showed that a single dose of rhSOD raised the concentration and activity of the antioxidant in serum, tracheal aspirate, and urine for 2 to 3 days. Inflammatory markers in the tracheal aspirates were reduced.

Toxicity: Renal dysfunction has been reported in animal studies when rhSOD was administered as a 50 mg/kg bolus. The smaller doses used in Rosenfeld’s study (Pediatr 1996; 97:811) were not associated with any abnormalities of renal function.

Preparation: Not commercially available