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IRCT2012092410430N3 IRCT 2013-05-24 Esfahan University of Medical Sciences Heated Humidified High Flow Nasal Cannula and RDS recovery in newborns A comparison of 2 interventions for the Heated Humidified High Flow Nasal Cannula (HHHFNC) in preterm infants weighing 1000g to 1500g in the recovery period from newborns Respiratory Distress Syndrome (RDS) 2012-09-22 anticipated 70 Complete https://irct.ir/trial/10941 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. N/A Newborn RDS. Intervention 1: Intervention Group: • For the newborns in the 7000PMH group the same procedure was applied except for the humidifying system for which the relative humidity and the temperature were set to 100% and 37oC at the end of the circuit, and also the temperature of the heater was set to 37 degrees while the temperature of the end probe was set to 40 degrees centigrade. Intervention 2: Control Group: For the MR850 group newborns; first of all appropriate nasal cannula was provided which its diameter was not more than 50% of the newborn's nostril (11). Then the nasal cannula was attached to the specific circuit and was linked to the Chamber exit while the entrance of the chamber was adjusted by the blender through a pressure manifold. The humidifying system was attached to the circuit through the Heater Wire and temperature probes and the system was set to Invasive status.
public Alireza Sadeghnia
Shahid Beheshti Hospital
Esfahan Iran (Islamic Republic of) +98 915 316 7951 sadeghnia@med.mui.ac.ir Esfahan University of Medical Sciences scientific Alireza Sadeghnia
Shahid Beheshti Hospital
Esfahan Iran (Islamic Republic of) +98 31109153167951 sadeghnia@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Newborns receiving surfactant due to affiliation with RDS and their oxygen saturation was equal or more than 90% under nCPAP with CDP=4 cm H2O and FiO2<30% during the last 4 hrs, who still needed oxygen supplement after disconnection from nCPAP were included in the study; the exclusion criteria for this study were if there was a congenital malformation; prenatal asphyxia (min 5 apgar score equals 0 to 3, or umbilical cord pH less than 7, and the Bicarbonate level of the umbilical cord was reported to be less than 12), or nasal mucosa erythematic. 1 year 30 years Both P22 Respiratory distress of newborn Treatment - Devices Treatment - Devices Intervention Group: • For the newborns in the 7000PMH group the same procedure was applied except for the humidifying system for which the relative humidity and the temperature were set to 100% and 37oC at the end of the circuit, and also the temperature of the heater was set to 37 degrees while the temperature of the end probe was set to 40 degrees centigrade. Control Group: For the MR850 group newborns; first of all appropriate nasal cannula was provided which its diameter was not more than 50% of the newborn's nostril (11). Then the nasal cannula was attached to the specific circuit and was linked to the Chamber exit while the entrance of the chamber was adjusted by the blender through a pressure manifold. The humidifying system was attached to the circuit through the Heater Wire and temperature probes and the system was set to Invasive status. Humidity. Timepoint: Every 6 hours. Method of measurement: Hygrometer. Esfahan University of Medical Sciences Approved 2011-09-23 Isfahan University of Medical Sciences Hezar Jerib St., Isfahan Isfahan Iran (Islamic Republic of)