Very Early Surfactant Without Mandatory Ventilation In Premature Infants Treated With Early Continuous Positive Airway Pressure-A Randomized Controlled Trial

Premature infants who are not intubated during the first 15 minutes of life and who develop clinical evidence of respiratory distress or need for oxygen requirement between 15 and 60 minutes of life, will be placed on bubble NCPAP of 6 cm H2O. Randomization envelops will them be opened and patients will be assigned to continuation on NCPAP alone (Control Group) or to NCPAP plus very early surfactant therapy (Treatment Group). Patients assigned to the treatment group will be transiently intubated for surfactant administration, extubated, and placed back on NCPAP of 6 cm H2O. Both groups will then be followed over time to determine which infants meet treatment failure criteria defined as: Treatment failure was defined a priori by either failure of adequate oxygenation or ventilation as follows: "1" FiO2 greater than 0.75 for more than 30 minutes to maintain SpO2 within the pre-established target ranges, "2" persistent or recurrent desaturation below 80% that did not respond to suctioning of the airways and PPV, "3" PCO2>65 mmHg and pH<7.22 on an arterial or capillary blood gas analysis, in association with increased work of breathing. Infants in the Treatment Group who cannot be extubated after their initial dose of surfactant because of clinical instability will be analyzed as treatment failures. Premature infants that meet treatment failure criteria on either arm will be intubated and placed on mechanical ventilation and given surfactant rescue doses according to the criteria of the participating institutions. Premature infants with respiratory distress syndrome who do not meet treatment failure criteria in both groups will remain on NCPAP until their respiratory failure improves.