Indomethacin treatment in patent ductus arteriosus. A double-blind study utilizing indomethacin plasma levels.

23 premature infants were placed on a randomized double-blind study to evaluate the effectiveness of indomethacin in closing a patent ductus arteriosus. Infants received 0.2 mg/kg indomethacin or placebo by gavage. In the treatment group, 7 patients responded out of a total of 12, while in the placebo group, 2 responded out of a total of 11. Indomethacin plasma levels were obtained in 6 patients in the treatment group. Plasma levels showed marked variability in peak level (60-3,100 ng/ml), time to peak level (0.5-6 h) and t1/2 (1 to greater than 24 h).