Comparison of three treatment regimens of natural surfactant preparations in neonatal respiratory distress syndrome.

UNLABELLED

The aim of the study was to compare the treatment regimen of three natural surfactants of different extraction and formulation (Alveofact [Surfactant A = SA], Poractant [Surfactant B = SB] and Beractant [Surfactant C = SC]) in neonatal respiratory distress syndrome (RDS). Premature infants of </=32 weeks' gestation with birth weight of </=2,000 g and with established RDS requiring artificial ventilation with a FiO2 >/=0.3 were randomly assigned to receive at least two doses of SA, SB or SC (100 mg/kg per dose). Infants who remained dependent on artificial ventilation with a FiO2 >/=0.3 received up to two additional doses. There were no differences among the groups regarding the necessity for more than two doses. The SA and the SB groups spent fewer days on a ventilator (p-value SA/SB 0.7, SA/SC 0.05, SB/SC 0.043) compared with the SC group, needed fewer days of oxygen administration (p-value SA/SB 0.14, SA/SC 0.05, SB/SC 0.04) and spent fewer days in hospital (p-value SA/SB 0.65, SA/SC 0.04, SB/SC 0.027). There were no statistically significant differences in the incidence of mortality, chronic lung disease, air leaks, necrotising enterocolitis, retinopathy of prematurity and intraventricular haemorrhage among the three groups.

CONCLUSION

The Alveofact and Poractant groups spent fewer days on the ventilator, needed fewer days of oxygen administration and spent fewer days in hospital compared with the Beractant group but no differences were observed among the three groups with regards to mortality and morbidity.