Comparison of the efficacy and complication of humidified high flow nasal cannula versus nasal continuous positive airway pressure after treatment with surfactant in neonate with respiratory distress syndrome: a randomized clinical trial

Objectives: To compare the efficacy and complication of humidified high flow nasal cannula versus nasal continuous positive airway pressure after treatment with surfactant in neonate with respiratory distress syndrome. Design: A randomized clinical trial. Setting and conduct: The eligible neonate with respiratory distress syndrome who will refer to Fatemieh Hospital during the study period will be enrolled into the trial. Inclusion criteria: Age of 28 to 36 months; premature neonate; affecting with respiratory distress syndrome; hospitalization in NICU with 24 hours after birth. Exclusion criteria: Being born in other hospitals. Intervention group: Treatment with surfactant 200 mg/kg for one week plus continuous positive airway pressure through the nasal mask with a pressure of 4 cm water and FIO2 equal to 40% for one week. Control group: Treatment with surfactant 200 mg/kg plus humidified high flow through bilateral nasal cannula with a pressure of 2 liter per minute for one week. Primary outcome: The need for intubation 72 hours after treatment with clinical examination. Secondary outcome: (a) number days required for respiratory protection 72 hours after treatment based on clinical examination; (b) duration of admission 72 hours after treatment according to medical records. Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots. Blinding: Not possible.

Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences