]>
IRCT20201222049802N1 IRCT 2021-02-28 Zanjan University of Medical Sciences A Comparative Study of Concomitant Intratracheal Administration of Surfactant with Budesonide with Surfactant alone in Premature Infants with Respiratory Distress Syndrome. A Comparative Study of Concomitant Intratracheal Administration of Surfactant with Budesonide with Surfactant alone in Premature Infants with Respiratory Distress Syndrome. 2021-01-04 anticipated 134 Complete https://irct.ir/trial/53241 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomized by random sequencing on 134 patients. For this aim we used from random allocation method (by the method of variable blocks). N/A Respiratory distress syndrome of newborn. Intervention 1: Intervention group: hospitalized infants receive 2.5 cc/kg Curosurf vial in combination with 1 cc/kg Pulmicort inhaler solution. Curosurf is a natural surfactant. each vial of Curosurf (Poractant alfa) used in this trial 3cc instillation suspension with contains 240mg phospholipid fraction from Porcine lung. ( Made by Chiesie Pharma company of Italy). The recommended starting dose is 100-200 mg/kg ( 1.25- 2.5ml/kg), additional doses of 100mg/kg (1.25 ml/kg), each at about 6-12hourly intervals may also be administered if needed. Pulmicort inhaler solution used in this trial is 2cc suspension with 0.25 mg/ml concentration containing Budesonide. (Made by Swedish manufacture ASTRAZENECA which is imported by Cobel Daru company). The vials should be warmed to room temperature by holding it in the hand for a few minutes, before use, and gently turned upside down a few times, without shaking, in order to obtain a uniform suspension. The suspensions should be withdrawn from the vials using a sterile needle and syringe and mixed gently. A suitable tube should then be used to instill Curosurf with Budesonide into the lung directly into the lower trachea by passing a catheter through the tube after intubation of patient. Intervention 2: Control group:hospitalized infants receive Curosurf vial alone. Curosurf is a natural surfactant. each vial of Curosurf (Poractant alfa) used in this trial 3cc instillation suspension contains 240mg phospholipid fraction from Porcine lung. (Made by Chiesie Pharma company of Italy). The recommended starting dose is 1.25 - 2.5ml/kg and additional doses is 1.25 ml/kg, each at about 6-12hourly intervals may also be administered if needed. The vial should be warmed to room temperature by holding it in the hand for a few minutes before to use, The suspension should be withdrawn from the vial using a sterile needle and syringe. A suitable tube should then be used to instill Curosurf into the lung directly into the lower trachea by passing a catheter through the tube after intubation of patient. 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 The release schedule will be announced soon.
public Asghar Marzban
Ayatollah Mousavi Hospital, Gavazang Ave, Shahid Sabouti Blvd, zanjan, iran.
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3342 0651 Drmarzban@zums.ac.ir Zanjan University of Medical Sciences scientific Asghar Marzban
Ayatollah Mousavi Hospital, Gavazang Ave, Shahid Sabouti Blvd, zanjan, iran.
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3342 0651 Drmarzban@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Premature Infant Less than 37 week's with Moderate or severe RDS Weight less than 2500 grams Requires Mechanical Ventilation Requires FiO2 more than 30% at Gestational age under 28 week's and more than 40% at Gestational age more than 28 week's. no limit 3 days Both Weight Less than 700 grams Severe Congenital Anomalies Fatal Cardiopulmonary Disease Other causes for Respiratory Distress Include Congenital Diaphragmatic Hernia P22.0 Respiratory distress syndrome of newborn Treatment - Drugs Treatment - Drugs Intervention group: hospitalized infants receive 2.5 cc/kg Curosurf vial in combination with 1 cc/kg Pulmicort inhaler solution. Curosurf is a natural surfactant. each vial of Curosurf (Poractant alfa) used in this trial 3cc instillation suspension with contains 240mg phospholipid fraction from Porcine lung. ( Made by Chiesie Pharma company of Italy). The recommended starting dose is 100-200 mg/kg ( 1.25- 2.5ml/kg), additional doses of 100mg/kg (1.25 ml/kg), each at about 6-12hourly intervals may also be administered if needed. Pulmicort inhaler solution used in this trial is 2cc suspension with 0.25 mg/ml concentration containing Budesonide. (Made by Swedish manufacture ASTRAZENECA which is imported by Cobel Daru company). The vials should be warmed to room temperature by holding it in the hand for a few minutes, before use, and gently turned upside down a few times, without shaking, in order to obtain a uniform suspension. The suspensions should be withdrawn from the vials using a sterile needle and syringe and mixed gently. A suitable tube should then be used to instill Curosurf with Budesonide into the lung directly into the lower trachea by passing a catheter through the tube after intubation of patient. Control group:hospitalized infants receive Curosurf vial alone. Curosurf is a natural surfactant. each vial of Curosurf (Poractant alfa) used in this trial 3cc instillation suspension contains 240mg phospholipid fraction from Porcine lung. (Made by Chiesie Pharma company of Italy). The recommended starting dose is 1.25 - 2.5ml/kg and additional doses is 1.25 ml/kg, each at about 6-12hourly intervals may also be administered if needed. The vial should be warmed to room temperature by holding it in the hand for a few minutes before to use, The suspension should be withdrawn from the vial using a sterile needle and syringe. A suitable tube should then be used to instill Curosurf into the lung directly into the lower trachea by passing a catheter through the tube after intubation of patient. Incidence of death. Timepoint: Incidence of death from admission to hospital discharge. Method of measurement: Physical examination. Incidence of Bronchopulmonary Dysplasia. Timepoint: Evaluation of Diagnostic criteria of Bronchopulmonary Dysplasia at 14 and 28 days after the start of the study. Method of measurement: Evaluation of Diagnostic criteria. Duration of hospitalization. Timepoint: At the time of discharge from the hospital. Method of measurement: Count the number of hospitalization days. Duration requires Mechanical ventilation. Timepoint: From patient admission to hospital discharge. Method of measurement: Count the days required for a mechanical ventilation. Incidence of Pneumothorax. Timepoint: From patient admission to hospital discharge. Method of measurement: Clinical observation and chest x ray. Incidence of pulmonary hemorrhage. Timepoint: From patient admission to hospital discharge. Method of measurement: Clinical observation and chest x ray. Incidence of Intraventricular hemorrhage. Timepoint: At 7, 14 and 30 days if hospitalized. Method of measurement: Brain Sonography. Oxygen index on the first and third day of treatment. Timepoint: the first and third day of treatment. Method of measurement: Calculated using the formula. Mean airway pressure multiplied by fraction of Inspired oxygen divided by arterial oxygen pressure multiplied by 100. Mean airway pressure on the first and third day of treatment. Timepoint: the first and third day of treatment. Method of measurement: Using the number calculated by the Ventilator. Need the next dose of Surfactant. Timepoint: The first three days of hospitalization. Method of measurement: Record patient file information. Mean systolic and diastolic blood pressure. Timepoint: The first and third day of treatment. Method of measurement: Using an oscillometric barometer attached to the monitor. Blood Sugar level. Timepoint: The first and third day of treatment. Method of measurement: Using a Glucometer. Zanjan University Of Medical Science Approved 2020-10-29 Ethics committee of Zanjan University of Medical Sciences Ayatollah Mousavi Hospital, Above Shahid Sabouti Boulevard, Gavazang Road, Zanjan, Iran. Zanjan Zanjan Iran (Islamic Republic of)