Comparison Of Intratracheal Administration Of Surfactant With Or Without Budesonide To Prevent Bronchopulmonary Dysplasia - A Randomized Pilot Study

Infants will be randomized into either the intervention group or control group, based on an assignment list designed by a statistician. Concealed randomization will be generated by a computer with permuted blocks in random sizes of six with half of the infants assigned to intervention and half to control. The control group will receive surfactant only (Curosurf - 200mg/kg initial dose; subsequent dose 100mg/kg (if applicable), Chiesi Farmaceutici, Parma, Italy) and the intervention group will receive Curosurf dose 200mg/kg initial dose; subsequent dose 100mg/kg (if applicable) plus budesonide (0.25 mg or 1 ml/kg). This dose will provide a concentration ratio of surfactant to budesonide greater than 50:1; this mixture was demonstrated, in an in vitro study using a surfactometer and high- performance liquid chromatography, not to affect the biophysical and  chemical properties of surfactant. Before intratracheal instillation, the syringe will be gently vortexed, and the surfactant or surfactant/budesonide mixture will be administered in a manner similar to that of routine surfactant therapy. Repeated administrations of surfactant/budesonide or surfactant only will be given every 6 hours to infants in the intervention or control group, respectively, until they require an FIO2 less than 0.3, or received a maximum of three doses