Background/aims Intra-tracheal instillation of surfactant/budesonide significantly improves pulmonary status in animals. The aim is to investigate if this therapy would decrease the incidence of BPD or death.

Methods and materials This randomised controlled trial comprised 265 VLBW infants who had: 1) severe radiographic RDS, 2) requirement of IMV (FIO₂ ≥ 0.5) shortly after birth: 131 received survanta (S) (100 mg/kg) and budesonide (B) (0.25 mg/kg) (S+B gr.), 134 received S only (100 mg/kg) (S gr). The sample size was determined based on the hypothesis that 60% of infants in the S group and 40% in the S+B group would die or develop BPD defined at 34 weeks postm. age.

ResultsThe S+B infant had lower tracheal aspirate interleukins 1, 6 and 8, lower OI, lower MAP in the early course of therapy, higher chance to wean to room air (p = 0.03). No significant immediate and long term adverse effects were observed. * NIH criteria

Conclusions In VLBW infants with severe RDS, administration of surfactant/budesonide significantly decreases the incidence of BPD and BPD or death with no apparent adverse side effects.