Table 9.

Secondary Outcome Measures of Safety

Exosurf
(n = 423)
%
Infasurf
(n = 423)
%
Risk Ratio*
(Infasurf/Exosurf)
95%
Confidence Interval
Pulmonary hemorrhage9.010.91.17(0.79, 1.74)
PDA
 Treated with indomethacin35.933.80.98(0.82, 1.16)
 Treated by surgical ligation13.715.41.09(0.81, 1.45)
  Total54.652.70.97(0.86, 1.09)
Apnea treated with xanthines67.470.21.04(0.96, 1.14)
Retinopathy of prematurity
 Stage ≥166.764.00.94(0.85, 1.04)
 Stage ≥315.919.91.22(0.89, 1.67)
Necrotizing enterocolitis (Bell stage ≥2)5.47.61.42(0.84, 2.42)
Sepsis28.432.21.14(0.94, 1.39)
Pneumonia12.514.71.14(0.83, 1.57)
  • * Adjusted for center and birth weight subgroups.