Bovine Surfactant Replacement Therapy in Neonates of Less than 32 Weeks' Gestation: A Multicenter Controlled Trial of Prophylaxis versus Early Treatment in China — a Pilot Study

Abstract

A domestic surfactant preparation has been used in China for a number of years. However, as for other surfactant preparations, there is debate among neonatologists regarding the optimal dose, mode of administration, and the best time of intervention. Objective: To evaluate whether prophylactic administration of surfactant is superior to early treatment in preterm infants < 32 weeks with a high risk of respiratory distress syndrome (RDS). Methods: We prospectively compared small premature infants (< 32 weeks) receiving 70 mg/kg bovine surfactant within 30 minutes after birth (prophylactic group, N = 116) with infants who received surfactant therapy for established RDS (early treatment group, N = 91). The primary outcome assessed was the incidence of RDS. The secondary outcomes assessed were severity of RDS, mortality, and bronchopulmonary dysplasia morbidity. Results: Compared with the early treatment group, the prophylactic group had a significantly better PaO2 (at 1 hour, 4 hours, and 12 hours postdose, respectively), better a/APO2 (at 1 hour, 4 hours, 12 hours, and 24 hours postdose, respectively), lower PaCO2 (at 1 hour postdose), and a significantly decreased need for mean airway pressure (MAP) and FiO2 on ventilation (p < 0.05). The prophylactic group had shorter durations for mechanical ventilation and supplemental oxygen compared with the early treatment group (p < 0.01 and p < 0.05, respectively). The incidence of RDS was comparable between the groups; however, the prophylactic group had a significantly lower incidence of severe RDS and significantly lower rate of repeated doses of surfactant than the early treatment group (p < 0.05). The incidences of bronchopulmonary dysplasia and patent ductus arteriosus were also lower in the prophylactic group than the early treatment group (p < 0.05). The two groups were comparable in mortality rate. Conclusion: In preterm infants under 32 weeks' gestation, prophylactic use of a domestic surfactant preparation is better than early surfactant treatment in improving pulmonary status and in decreasing the incidence of severe RDS and duration on mechanical ventilation.

Keywords

• bovine surfactant
• premature infants
• prophylactic administration
• respiratory distress syndrome