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IRCT2015123110430N7 IRCT 2016-05-10 Isfahan University of Medical Sciences-Vice chancellery of Research and Technology The comparison of the effect of NIPPV and nCPAP on Brain Tissue Oxygen content in Preterm Neonates Weighing less than 1500 gr with Respiratory Distress Syndrome The comparison of the effect of NIPPV and nCPAP on Brain Tissue Regional Oximetry in Preterm Neonates Weighing less than 1500 gr with RDS 2015-05-22 anticipated 32 Complete https://irct.ir/trial/10945 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention. N/A studying the brain tissue oxymetry. Intervention 1: Control Group: In this group, neonates are treated with nCPAP for two hours with two-hour intervals. Intervention 2: Intervention Group: In this group, neonates are treated with NIPPV for two hours with two-hour intervals.
public Dr. Alireza Sadeghnia
Isfahan University of Medical Sciences, Isfahan
Isfahan Iran (Islamic Republic of) +98 31 3335 1777 asadeghnia@gmail.com Isfahan University of Medical Sciences scientific Dr. Alireza Sadeghnia
Isfahan
Isfahan Iran (Islamic Republic of) +98 31 3335 1777 asadeghnia@gmail.com Isfahan University of Medical Sciences Iran (Islamic Republic of) Inclusion Criteria: preterm infants weighing less than 1500 gr who had been put under nCPAP respiratory support within 72 hours from birth due to RDS, and also received their first surfactant administration during the first two hours; RDS symptoms such as tachypnea, intercostal retraction, nasal flaring, grunting, and radiography suggestive of RDS; Survanta administration to achieve FiO2≥30% and CDP≥5 cm H2O in order to maintain SpO2 in the range of 89-95% in the right hand; IF at 72 hours from birth, newborns were under nCPAP respiratory support, and if in order to maintain SpO2 in the range of 89-95% in the right hand, CDP was in the range of 4 to 6 cm H2O, with FiO2 at 30% to 40%. EXCLUSION CRITERIA: Prenatal Asphyxia (5 min Apgar between 0 to 3, umbilical cord pH less than 7, and umbilical cord Bicarbonate less than 12mEq/L), and congenital disorders; newborns whose first dose of surfactant was administered later than 2 hours from birth; newborns who did not receive surfactant; newborns whose echocardigraphy revealed PDA symptoms; newborns who are under inotrope drugs administration; newborns whose cranial sonography suggested grade III to IV GM-IVH; newborns with air leak symptoms 3 days 14 days Both P52.2 Intraventricular (nontraumatic) haemorrhage, grade 3, of fetus and newborn Treatment - Other Treatment - Other Control Group: In this group, neonates are treated with nCPAP for two hours with two-hour intervals Intervention Group: In this group, neonates are treated with NIPPV for two hours with two-hour intervals Brain tissue oxygenation. Timepoint: third day, seventh day, fourteenth day. Method of measurement: Near Infrared Spectroscopy. Intraventicular hemorrhage. Timepoint: daily. Method of measurement: transcranial sonography. Isfahan University of Medical Sciences-Vice chancellery of Research and Technology Approved 2015-01-20 Isfahan University of Medical Sciences Ethics Committee Faculty of Medicine, Isfahan University of MEdical Sciences Isfahan Iran (Islamic Republic of)