]>
IRCT20120728010430N8 IRCT 2019-05-12 Esfahan University of Medical Sciences Investigating CPAP in Treatment of RDS Comparison of Ventilators Work of Breath Based on Constant flow nasal CPAP through Pressure Limited and Electronic Feedback Pressure Control Mechanisms in the Treatment of Respiratory Distress Syndrome in Neonates Weighing 1000 grams 2015-08-01 anticipated 70 Complete https://irct.ir/trial/38534 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Neonates whose first file number digit was an even number were put in PC-nCPAP group and those with an odd first file number digit were grouped as PL-nCPAP. N/A Respiratory distress syndrome of newborn. Intervention 1: Control group: Neonates in PL-nCPAP group were supported with nCPAP respiratory support using Nasal prong Argyle (Covidien, Mansfield, USA) with the aid of Christina ventilator (Stephan, Medizintechnik, Hamburg, Germany). The primary CDP level was set as 6 cmH2O and FiO2=30%. The neonates who needed an inhaled oxygen fraction higher than 40% in order to keep oxygen saturation level at 90%-95% in their right hands received 100 mg/kg of Survanta using INSURE method. Then, if the neonates’ need of inhaled oxygen fraction higher than 40% was kept constant at acceptable levels, Survanta was administered again 6 hours after administration of the previous surfactant dose, which continued maximally for 4 doses. CBG (Capillary Blood Gas) was performed before and after surfactant administration and then continued every 12 hours and, based on that, related mechanical ventilation management alterations were made. Patients with any of the following conditions would be discontinued from non-invasive ventilation and would then undergo intubation and invasive ventilation:• Despite a CDP of 8 cmH2O and FiO2≤75%, inability to keep oxygen saturation level at 90% to 95% in their right hands. Gasometric indices in CBG showing respiratory failure (pH<7.2 & PCO2>65 mmHg). More than 3 times of apnea per hour requiring ventilation using a bag and a mask. During respiratory management, in instances when a neonate’s need for fraction of inspirated oxygen in levels lower than 50% was kept constant for more than 4 hours, CDP gradually dropped 1 to 2 cmH2O to keep O2Sat at an acceptable range. At CDP=4 cmH2O and Fio2<30%, the neonate was weaned from respiratory support. Intervention 2: Intervention group: Neonates in PC-nCPAP group were provided with nCPAP respiratory support including Nasal prong Argyle (Covidien, Mansfield, USA) and Servo-i ventilator (Maquet, Solna, Sweden). Servo-I was equipped with a non-invasive ventilation software program and the users selected ‘Non-Invasive Ventilation’ and ‘nCPAP’ prior to activating ventilation. The primary CDP level was set as 6 cmH2O and FiO2=30%. The neonates who needed an inhaled oxygen fraction higher than 40% in order to keep oxygen saturation level at 90%-95% in their right hands received 100 mg/kg of Survanta using INSURE method. Then, if the neonates’ need of inhaled oxygen fraction higher than 40% was kept constant at acceptable levels, Survanta was administered again 6 hours after administration of the previous surfactant dose, which continued maximally for 4 doses. CBG (Capillary Blood Gas) was performed before and after surfactant administration and then continued every 12 hours and, based on that, related mechanical ventilation management alterations were made. Patients with any of the following conditions would be discontinued from non-invasive ventilation and would then undergo intubation and invasive ventilation:• Despite a CDP of 8 cmH2O and FiO2≤75%, inability to keep oxygen saturation level at 90% to 95% in their right hands. Gasometric indices in CBG showing respiratory failure (pH<7.2 & PCO2>65 mmHg). More than 3 times of apnea per hour requiring ventilation using a bag and a mask. During respiratory management, in instances when a neonate’s need for fraction of inspirated oxygen in levels lower than 50% was kept constant for more than 4 hours, CDP gradually dropped 1 to 2 cmH2O to keep O2Sat at an acceptable range. At CDP=4 cmH2O and Fio2<30%, the neonate was weaned from respiratory support. Yes - There is a plan to make this available What will be shared: Calculation method for primary and secondary objectives When: April, 2019 to April 2020 To whom: Medical researchers in the field of neonatology Conditions: No limitations exist on data analysis. Where to obtain: E-mailing the corresponding author How to obtain: No limitations exist. Comments:
public Alireza Sadeghnia
No. 5, Alley 56, Forooghi St., Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8137978811 +98 31 3335 1777 asadeghnia@gmail.com Esfahan University of Medical Sciences scientific Alireza Sadeghnia
No. 5, Alley 56, Forooghi St., Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8137978811 +98 31 3335 1777 asadeghnia@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) neonates weighing 1000 grams with respiratory distress syndrome (Tachypnea, Intercostal retraction, nasal flaring, granting, needing inspired oxygen fraction higher than 21%) 1 day no limit Both congenital anomaly and perinatal asphyxia (5-minute apgar score between 0 and 3, umbilical cord ph less than 7 and umbilical cord bicarbonate less than 12 mEq/Lit) P22.0 Respiratory distress syndrome of newborn Treatment - Devices Treatment - Devices Control group: Neonates in PL-nCPAP group were supported with nCPAP respiratory support using Nasal prong Argyle (Covidien, Mansfield, USA) with the aid of Christina ventilator (Stephan, Medizintechnik, Hamburg, Germany). The primary CDP level was set as 6 cmH2O and FiO2=30%. The neonates who needed an inhaled oxygen fraction higher than 40% in order to keep oxygen saturation level at 90%-95% in their right hands received 100 mg/kg of Survanta using INSURE method. Then, if the neonates’ need of inhaled oxygen fraction higher than 40% was kept constant at acceptable levels, Survanta was administered again 6 hours after administration of the previous surfactant dose, which continued maximally for 4 doses. CBG (Capillary Blood Gas) was performed before and after surfactant administration and then continued every 12 hours and, based on that, related mechanical ventilation management alterations were made. Patients with any of the following conditions would be discontinued from non-invasive ventilation and would then undergo intubation and invasive ventilation:• Despite a CDP of 8 cmH2O and FiO2≤75%, inability to keep oxygen saturation level at 90% to 95% in their right hands. Gasometric indices in CBG showing respiratory failure (pH<7.2 & PCO2>65 mmHg). More than 3 times of apnea per hour requiring ventilation using a bag and a mask. During respiratory management, in instances when a neonate’s need for fraction of inspirated oxygen in levels lower than 50% was kept constant for more than 4 hours, CDP gradually dropped 1 to 2 cmH2O to keep O2Sat at an acceptable range. At CDP=4 cmH2O and Fio2<30%, the neonate was weaned from respiratory support. Intervention group: Neonates in PC-nCPAP group were provided with nCPAP respiratory support including Nasal prong Argyle (Covidien, Mansfield, USA) and Servo-i ventilator (Maquet, Solna, Sweden). Servo-I was equipped with a non-invasive ventilation software program and the users selected ‘Non-Invasive Ventilation’ and ‘nCPAP’ prior to activating ventilation. The primary CDP level was set as 6 cmH2O and FiO2=30%. The neonates who needed an inhaled oxygen fraction higher than 40% in order to keep oxygen saturation level at 90%-95% in their right hands received 100 mg/kg of Survanta using INSURE method. Then, if the neonates’ need of inhaled oxygen fraction higher than 40% was kept constant at acceptable levels, Survanta was administered again 6 hours after administration of the previous surfactant dose, which continued maximally for 4 doses. CBG (Capillary Blood Gas) was performed before and after surfactant administration and then continued every 12 hours and, based on that, related mechanical ventilation management alterations were made. Patients with any of the following conditions would be discontinued from non-invasive ventilation and would then undergo intubation and invasive ventilation:• Despite a CDP of 8 cmH2O and FiO2≤75%, inability to keep oxygen saturation level at 90% to 95% in their right hands. Gasometric indices in CBG showing respiratory failure (pH<7.2 & PCO2>65 mmHg). More than 3 times of apnea per hour requiring ventilation using a bag and a mask. During respiratory management, in instances when a neonate’s need for fraction of inspirated oxygen in levels lower than 50% was kept constant for more than 4 hours, CDP gradually dropped 1 to 2 cmH2O to keep O2Sat at an acceptable range. At CDP=4 cmH2O and Fio2<30%, the neonate was weaned from respiratory support. The average Work of Breath in PC- nCPAP and PL- nCPAP. Timepoint: Every 6 hours. Method of measurement: expiratory tidal volume multiplied by dynamic pressure. Esfahan University of Medical Sciences Approved 2016-04-20 Ethics committee of University of Medical Sciences of Isfahan Hezar Jarib St., Azadi Sq., Isfahan, Iran Isfehan Isfehan Iran (Islamic Republic of)