Surfactant replacement therapy: a multicentric trial comparing two dosage approaches.

In this study the results of two different initial doses (Group A: 200 mg/kg--82 patients; Group B: 100 mg/kg--83 patients) of a porcine surfactant were compared in the treatment of neonatal respiratory distress syndrome. Main entry criteria were: birth weight between 700 and 2,000 grams, need of mechanical ventilation, FiO2 > or = 0.60 to obtain a PaO2 between 50 and 80 mmHg (PaO2/FiO2 < or = 133.3 mmHg) and less than 15 hours of postnatal age. Two further 100 mg/kg doses could be given in both groups at 12 hours interval if FiO2 was > 0.40. Birth weight (Group A: 1,231 +/- 281 g. and Group B: 1,324 +/- 355 g.), gestational age (Group A: 29.9 +/- 2.7 wk. and Group B: 30.6 +/- 2.6 wk.) and Apgar scores were similar in the two groups. Group A had a significantly higher mean PaO2/FiO2 ratio (p < 0.05) after 12 hours--178 (40-506) vs 133 (17-243) mmHg, before receiving a 2nd dose, after 24 hours--180 (17-431) vs 152 (39-360), and in the 3rd day--177 (40-333) vs 124 (24-249) and needed a lower FiO2 (p < 0.05) after 36 hours (0.47 +/- 0.20 vs 0.53 +/- 0.23) and on the 3rd day (0.51 +/- 0.23 vs 0.61 +/- 0.24). The mean peak inspiratory pressure was lower in Group A at 36 hours (17.5 +/- 4.5 vs 20.6 +/- 6.8) after the initial dose (p < 0.05). The time of exposure to high oxygen concentrations (FiO2 > or = 0.40) was lower in Group A--85 (3-643) vs 131 (3-672) hours; p < 0.05). Total amount of phospholipids given per patient was meanly 224 mg in Group A and 144 mg in Group B. Mortality was lower in group A but without significant difference (Group A: 17/82; Group B: 26/83). The analysis of the subgroup of babies with less than 1,500 gr. at birth showed a statistically significant difference in mortality (Group A: 15/70; Group B: 24/56; p < 0.02).