Long-term follow-up of premature infants treated with prophylactic, intratracheal recombinant human CuZn superoxide dismutase.

Academic Article

Abstract

  • OBJECTIVE: To examine the long-term effects of treatment with recombinant human CuZn superoxide dismutase (rhSOD) in infants enrolled previously in two placebo-controlled trials. STUDY DESIGN: Records for 46 (88%) infants were examined, with 19 infants having received either single or multiple intratracheal (i.t.) doses of placebo, 12 having received a single i.t. dose of rhSOD, and 15 having received multiple i.t. doses of rhSOD. Mean age at follow-up was 28 months corrected age. Records were examined for neurologic dysfunction, developmental delay, and any significant medical disorders. RESULTS: Four placebo infants (21%) had evidence of neurodevelopmental abnormalities and four infants developed asthma. Four single-dose rhSOD infants (33%) had neurodevelopmental abnormalities and two infants developed asthma. One multiple-dose rhSOD infant had evidence of neurodevelopmental abnormalities and one developed asthma. No other differences were found between the placebo and rhSOD groups. CONCLUSION: Preliminary data suggest that rhSOD is safe and not associated with any long-term adverse effects. Further results will depend on the results of multicenter trials of rhSOD in preterm infants.
  • Authors

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    Keywords

  • Administration, Inhalation, Bronchopulmonary Dysplasia, Controlled Clinical Trials as Topic, Dose-Response Relationship, Drug, Female, Follow-Up Studies, Humans, Infant, Newborn, Infant, Premature, Diseases, Male, Pilot Projects, Prognosis, Prospective Studies, Recombination, Genetic, Respiratory Distress Syndrome, Newborn, Risk Assessment, Superoxide Dismutase, Time Factors
  • Author List

  • Davis JM; Richter SE; Biswas S; Rosenfeld WN; Parton L; Gewolb IH; Parad R; Carlo W; Couser RJ; Baumgart S
  • Start Page

  • 213
  • End Page

  • 216
  • Volume

  • 20
  • Issue

  • 4