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IRCT20151123025202N9 IRCT 2020-06-19 Hamedan University of Medical Sciences Treatment of respiratory distress syndrome in preterm infants Comparison of two methods of respiratory support: Nasal Continuous positive Airway Pressure (NCPAP) and Nasal Intemitant Positive Pressure Ventilation (NIPPV) after less invasive surfactant administration (LISA) in preterm infants 28 to 36 weeks of age with respiratory distress syndrome, a Randomized clinical trial 2020-01-15 anticipated 96 Complete https://irct.ir/trial/48069 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We will provide 96 cards and will write letter I on 48 for intervention and on the other 48 letter C for the control group. Then put them inside the envelope with aluminum wrap and put in a box. At the time of patient arrival, randomly select one of the envelopes and open it, based on selected letter ( I or C) patients assign it to the intervention or control group, Blinding description: The person evaluating the outcome will be unaware of the type of intervention. 3 neonatal respiratory distress syndrome. Intervention 1: Intervention group: Nasal Intermittent Positive Pressure Ventilation (NIPPV) after less invasive surfactant administration (LISA). This group intermittently will expose to higher levels of air pressure through the same device attached to the nose. Maximum Respiratory Pressure Group (PIP) receives 18-20 cm H2O, PEEP 5-6 cm H2O, respiratory rate 30-40 per minute, Inhalation time 0.35-0.40 seconds, flow rate 6-8 liters per minute. Intervention 2: Control group: Nasal Continuous positive Airway Pressure (NCPAP). This Group will apply continuous airway pressure through a mask or nose pendulum with 4 cm of water pressure and 40% fraction of inspired oxygen. When saturation 4 cm water, , FIO2 less than 30% and oxygen saturation 90 to 94% achieved, CPAP will be disconnected and the patient will be under oxygen therapy with oxy hood. By improving the quality of the baby's oxygen supply, we gradually reduce the PIP by 2 cm to 14 cm. Then the respiratory rate will be reduced by 5 to 10 per minute Until spontaneous breathing increases. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Abbas Moradi
Hamedan shahid fahmideh street medicine school
Hamedan Iran (Islamic Republic of) 6517838736 +98 81 3838 0097 a.moradi@umsha.ac.ir Hamedan University of Medical Sciences scientific Abbas Moradi
Hamedan shahid fahmideh street medicine school
Hamedan Iran (Islamic Republic of) 6517838736 +98 81 3838 0097 a.moradi@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) gestational age of 28-37 weeks With distress syndrome Fraction of inspired oxygen>40 Require treatment with surfactant in less than 24 hours after birth 1 day 28 days Both APGAR score<5 Suffering from any congenital disease P22.0 Respiratory distress syndrome of newborn Treatment - Devices Treatment - Devices Intervention group: Nasal Intermittent Positive Pressure Ventilation (NIPPV) after less invasive surfactant administration (LISA). This group intermittently will expose to higher levels of air pressure through the same device attached to the nose. Maximum Respiratory Pressure Group (PIP) receives 18-20 cm H2O, PEEP 5-6 cm H2O, respiratory rate 30-40 per minute, Inhalation time 0.35-0.40 seconds, flow rate 6-8 liters per minute. Control group: Nasal Continuous positive Airway Pressure (NCPAP). This Group will apply continuous airway pressure through a mask or nose pendulum with 4 cm of water pressure and 40% fraction of inspired oxygen. When saturation 4 cm water, , FIO2 less than 30% and oxygen saturation 90 to 94% achieved, CPAP will be disconnected and the patient will be under oxygen therapy with oxy hood. By improving the quality of the baby's oxygen supply, we gradually reduce the PIP by 2 cm to 14 cm. Then the respiratory rate will be reduced by 5 to 10 per minute Until spontaneous breathing increases Respiratory support. Timepoint: First week of birth. Method of measurement: Investigation of FIO2 and analysis of arterial blood gases. Hospitalization duration. Timepoint: From hospitalization to discharge. Method of measurement: Review of infant medical records. Mortality. Timepoint: From hospitalization to discharge. Method of measurement: Review of infant medical records. Hamedan University of Medical Sciences Approved 2020-01-11 Ethics committee of Hamadan Univercity of Medical Science ُShahid Fahmideh Vvenue Hamadan Hamadan Iran (Islamic Republic of)