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IRCT2015100814333N41 IRCT 2015-10-19 Vice chancellor for research, Kermanshah University of Medical Sciences Comparison of the effects of High flow nasal cannula versus nasal continuous positive Air way pressure in treatment of respiratory distress syndrome in premature newborns A comparative study of effectiveness and ineffectiveness of the nasal cannula with high pressure and continuous positive airway pressure through the nose for the treatment of premature infants with respiratory distress syndrome 2015-07-06 anticipated 200 Complete https://irct.ir/trial/13975 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Random method according to the random number table. N/A Respiratory distress syndrome. Intervention 1: In the first group after the injection of the surfactant and Extube, Placed under respiratory support with nasal (CPAP) and initiation of treatment is with 4 ml of water and Fio2 40%. Then the duration of treatment with nasal or nasal cannula, need for mechanical ventilation, need to prescribe another dose of surfactant, damage to the nasal septum, intracerebral bleeding, during and end of the study is investigated. Intervention 2: In the second group respiratory support is established using the oxygen hot and humid high flow through nasal cannula (HFNC). Blender and nasal cannula devices with an inner diameter of 2 mm is used for administering oxygen. Then the duration of treatment with nasal or nasal cannula, need for mechanical ventilation, need to prescribe another dose of surfactant, damage to the nasal septum, intracerebral bleeding, during and end of the study is investigated.
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scientific Dr. Homa Babaei
Emam Reza Hospital, Parastar Boulevard
Kermanshah Iran (Islamic Republic of) +98 83 3427 6300 HOMA_BABAEI@KUMS.AC.IR Kermanshah University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: premature infants under 37 weeks and over 24 weeks; respiratory distress syndrome; written informed consent of the parents Exclusion criteria: Apgar score of fifth minute less than 5; there are syndromes or major congenital anomalies; congenital heart disease, mother Radiography and chorioamnionitis 6 months 9 months Both P22 Respiratory distress syndrome of newborn Treatment - Drugs Treatment - Drugs In the first group after the injection of the surfactant and Extube, Placed under respiratory support with nasal (CPAP) and initiation of treatment is with 4 ml of water and Fio2 40%. Then the duration of treatment with nasal or nasal cannula, need for mechanical ventilation, need to prescribe another dose of surfactant, damage to the nasal septum, intracerebral bleeding, during and end of the study is investigated In the second group respiratory support is established using the oxygen hot and humid high flow through nasal cannula (HFNC). Blender and nasal cannula devices with an inner diameter of 2 mm is used for administering oxygen. Then the duration of treatment with nasal or nasal cannula, need for mechanical ventilation, need to prescribe another dose of surfactant, damage to the nasal septum, intracerebral bleeding, during and end of the study is investigated Cerebral hemorrhage. Timepoint: During study. Method of measurement: By cerebral ultrasound. Necrotizing enterocolitis. Timepoint: During study. Method of measurement: Based on the clinical symptoms and a doctor observation and an abdominal radiograph. Amount of nasal septum injury. Timepoint: During study. Method of measurement: Based on the doctor examination. Air leak syndrome. Timepoint: During study. Method of measurement: Based on the clinical symptoms and doctor observation and chest radiography. Broncho-pulmonary dysplasia. Timepoint: During study. Method of measurement: Based on the clinical symptoms, doctor observation, x-ray and laboratory. The need for re-intubating. Timepoint: During study. Method of measurement: Based on laboratory and doctor clinical examination. Vice chancellor for research, Kermanshah University of Medical Sciences Approved 2015-08-18 Ethics committee of Kermanshah University of Medical Sciences Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences Kermanshah Iran (Islamic Republic of)