Copper-Zinc Superoxide Dismutase Helps Premature Infants

Laurie Barclay, MD

March 07, 2003

March 7, 2003 -- Premature infants benefit from being treated at birth with recombinant human copper-zinc superoxide dismutase (r-h CuZnSOD), according to the results of a randomized trial reported in the March issue of Pediatrics.

"Because the lungs of critically ill premature infants are exposed to supraphysiological oxygen concentrations at birth, oxidative insult may be an extremely important component of the injury process," write Jonathan M. Davis, MD, from Winthrop University Hospital, SUNY Stony Brook School of Medicine in Mineola, New York, and colleagues. "A promising intervention that may prevent chronic respiratory morbidity and bronchopulmonary dysplasia is prophylactic supplementation with recombinant human antioxidant enzymes."

In this randomized study, 302 premature infants (birth weight, 600-1200 g) treated with exogenous surfactant at birth for respiratory distress syndrome received either intratracheal r-h CuZnSOD (5 mg/kg in 2 mL/kg saline) or placebo every 48 hours for as long as intubation was required, up to 1 month of age.

At 28 days of life or 36 weeks' postmenstrual age, there were no differences between groups in mortality or in the development of bronchopulmonary dysplasia. Treatment with r-h CuZnSOD was well-tolerated, without significant increases in any adverse event.

At a median of 1 year corrected age, 209 surviving infants (80%) had health assessments and physical examinations, and 189 had complete data available. Episodes of wheezing or other respiratory illness requiring treatment with bronchodilators and/or corticosteroids occurred in 37% of the placebo group and in 24% of the r-h CuZnSOD group (36% reduction).

Among infants of less than 27 weeks' gestation, asthma medications were given to 42% of the placebo group and to 19% of the r-h CuZnSOD-treated infants. Compared with infants who received placebo, those who received r-h CuZnSOD had a 55% decrease in asthma medications, a 55% decrease in emergency department visits, and a 44% decrease in subsequent hospitalizations. Growth measurements and physical findings were similar in both groups.

"These data indicate that treatment at birth with r-h CuZnSOD may reduce early pulmonary injury, resulting in improved clinical status when measured at 1 year corrected age," the authors write. "r-h CuZnSOD appears to be a safe and effective therapy that improves pulmonary outcome in high-risk premature infants."

Bio-Technology General Corporation supported this study and has financial arrangements with some of its authors.

Pediatrics. 2003;111:469-476

Reviewed by Gary D. Vogin, MD


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