rhSOD,a human recombinant antioxidant,has been given to premature infants(700-1300g) with respiratory distress syndrome in an attempt to prevent oxidant induced lung injury and the development of bronchopulmonary dysplasia. In order to examine the long term effects of treatment with rhSOD,infants previously enrolled in 2 placebo controlled trials were studied. Records for 41 (72%) of the infants were obtained from either neonatal follow-up programs or pediatrician's offices. Eighteen infants received either a single or multiple doses of placebo, 9 infants received a single intratracheal dose of rhSOD just after birth, and 14 received multiple intratracheal doses (given every 48 hours up to 7 doses). Mean age at follow-up was 16±6 months corrected age. Records were examined for evidence of neurological handicap which was classified as mild-moderate (hyper- or hypotonia) or moderate-severe(spastic diplegia/significant motor delay); developmental delay (mild or global); or any significant medical disorder. Results are presented in the table below (*some infants had both neurologic and developmental abnormalities). Two infants developed hypothyroidism, 1 infant in the placebo group who had mild neurologic abnormalities and global developmental delay and 1 infant in the multiple dose rhSOD group with mild neurologic and mild developmental delays.

Table 1 No caption available.
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There were no differences in neurologic abnormalities, developmental delay, or any pulmonary or renal sequelae between rhSOD treated infants and the placebo group. No infant treated with multiple doses of rhSOD had any evidence of significant long term neurologic or developmental delay, suggesting that rhSOD is safe and not associated with any long-term adverse effects.