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IRCT20201222049795N1 IRCT 2021-01-09 Semnan University of Medical Sciences A comparison of the effect of Nasal Continuous Positive Airway Pressure (NCPAP) vs Nasal high-frequency oscillation(NHFO) in the treatment of respiratory distress in preterm infants Nasal Continuous positive Airway Pressure (NCPAP); Nasal high-frequency oscillation(NHFO) A comparison of the effect of Nasal Continuous Positive Airway Pressure (NCPAP) vs Nasal high-frequency oscillation(NHFO) in the treatment of respiratory distress in preterm infants 2020-09-30 anticipated 20 Complete https://irct.ir/trial/53176 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly assigned to two groups of intervention and control with 10 members using block randomization with block sizes of 2. Randomized permutation blocks (block 2). Excel software rand function was used for randomization, Blinding description: The participants are infants and it will be impossible for them to explain the method, treatment groups, and how to randomize; Therefore, participants will not be aware of the type of intervention received and are blinded. N/A Neonatal respiratory distress syndrome. Intervention 1: First intervention group: Nasal Continuous Positive Airway Pressure group; These infants underwent non-invasive ventilation Continuous Positive Airway Pressure using Bi nasal prong, Bubble Continuous Positive Airway Pressure, hot and humid airflow, and blender. Continuous Positive Airway Pressure was started with 5 cmH2O to keep the Saturation between 90 to 94 percent. Intervention 2: Second Intervention group: Nasal high-frequency oscillation group, These infants underwent non-invasive mechanical ventilation using CNO devices for Medin company and Bi nasal prong and using oscillation and periodic opening and closing of the air outlet valve. Ventilation started by using CPAP with 5 cmH2O, frequency of 10 Hz, and oscillation that started with 5. At the beginning of ventilation, visible vibration of the upper chest was noted. It was started to keep the Saturation between 90 to 94 percent. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Maryam Jandaghi
No 265, Bagh Ferdos Ave, Shahid Ghods Ave, Amitis Apartment
Semnan Iran (Islamic Republic of) 3514618563 +98 23 3332 3194 M.Jandaghi73@gmail.com Islamic Azad University scientific Maryam Jandaghi
No 265, Bagh Ferdos Ave, Shahid Ghods Ave, Amitis Apartment
Semnan Iran (Islamic Republic of) 3514618563 +98 23 3332 3194 M.Jandaghi73@gmail.com Islamic Azad University Iran (Islamic Republic of) Gestational age between 25 to 35 weeks Moderate to severe respiratory distress syndrome no limit no limit Both Patients with congenital anomalies Patients needed endotracheal intubation P22.0 Respiratory distress syndrome of newborn Treatment - Devices Treatment - Devices First intervention group: Nasal Continuous Positive Airway Pressure group; These infants underwent non-invasive ventilation Continuous Positive Airway Pressure using Bi nasal prong, Bubble Continuous Positive Airway Pressure, hot and humid airflow, and blender. Continuous Positive Airway Pressure was started with 5 cmH2O to keep the Saturation between 90 to 94 percent. Second Intervention group: Nasal high-frequency oscillation group, These infants underwent non-invasive mechanical ventilation using CNO devices for Medin company and Bi nasal prong and using oscillation and periodic opening and closing of the air outlet valve. Ventilation started by using CPAP with 5 cmH2O, frequency of 10 Hz, and oscillation that started with 5. At the beginning of ventilation, visible vibration of the upper chest was noted. It was started to keep the Saturation between 90 to 94 percent. Preterm infants. Timepoint: Determining premature infants at the beginning of the study. Method of measurement: By measuring gestational age between 25 to 35 weeks. Respiratory distress. Timepoint: At the beginning of the study. Method of measurement: Using medical examinations. O2 Therapy. Timepoint: at any time interval of study If it's needed. Method of measurement: Using medical examinations. O2 Therapy time. Timepoint: While O2 Therapy. Method of measurement: Counting the days of oxygen therapy. Invasive mechanical ventilation. Timepoint: at any time interval of study If it's needed. Method of measurement: If the infant does not respond to non-invasive mechanical ventilation. Duration of using mechanical ventilation. Timepoint: While using mechanical ventilation. Method of measurement: Counting the days of using mechanical ventilation and Using the data collection form. The infant's age at the time of use of mechanical ventilation. Timepoint: While using mechanical ventilation. Method of measurement: Age is calculated based on hours and Using the data collection form. Apnea. Timepoint: At any time of apnea During or after being placed under the studied devices. Method of measurement: By observing the infant's breathing measuring devices. The infant's age at the time of apnea. Timepoint: At any time of apnea. Method of measurement: Age is calculated based on hours and Using the data collection form. Surfactant. Timepoint: At any time of study if necessary. Method of measurement: Based on the physician's opinion and when there is no progress in the infant's respiratory recovery. Age of infants at surfactant indication. Timepoint: At the time of surfactant indication. Method of measurement: Age is calculated based on hours and Using the data collection form. Pneumothorax. Timepoint: During or after being placed under the studied devices. Method of measurement: By imaging and examination. Age of infant's at the pneumothorax incidence. Timepoint: At the time of pneumothorax incidence. Method of measurement: Age is calculated based on hours and Using the data collection form. IVH (Intra ventricular hemorrhage). Timepoint: During or after being placed under the studied devices. Method of measurement: imaging. Age of infant's at intraventricular hemorrhage. Timepoint: At the time of intraventricular hemorrhage. Method of measurement: Age is calculated based on hours and Using the data collection form. CLD (Chronic Lung Disease). Timepoint: after being placed under the studied devices. Method of measurement: imaging and examination. Semnan University of Medical Sciences Approved 2020-09-30 Ethics committee of Islamic Azad University- Shahrood Branch No.256, Amitis Apartment, Shahid Qods Ave, Bagh Ferdos Ave, Semnan Shahrood Semnan Iran (Islamic Republic of)