]>
IRCT20180821040847N1 IRCT 2018-09-10 Ahvaz University of Medical Sciences ."Effect of nasal continuous positive air way pressure on the clinical course of neonates with respiratory distress syndrome" ."Effect of nasal duo positive air way pressure on the clinical course of neonates with respiratory distress syndrome" The effect of assisted ventilation using nasal continuous positive air way pressure versus nasal duo positive air way pressure on the clinical course of neonates with gestational age between 28-34 week with respiratory distress syndrome :A randomized controlled trial. 2018-09-23 anticipated 148 Complete https://irct.ir/trial/33454 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study ,individuals are randomly divided into two groups of nasal continuous positive air way pressure and duo positive air way pressure based on random quadratic randomization method which is cited by the http://www.sealedenvelope.com/simple-randomiser/v1/lists site, Blinding description: In this study patient who are actually neonate,after obtaining consent from the parents ,randomly enter the study .And the implementation of the study is the responsibility of the therapist ,and the neonate does not interfere with the setting of the device.Also Researcher and data analyst do not interfere with the implementation of the study . N/A Respiratory distress syndrom. Intervention 1: Intervention group:The first group is neonates who are under nasal continuous positive air way pressure. fabian device from switzerland country , is used to apply this method. Intervention 2: Intervention group: In second group ,neonate are under nasal duo positive air way pressure .Fabian device from switzerland country,is used to apply this method. No - There is not a plan to make this available Justification or reason for not sharing IPD is Considering that this study will be carried out for the first time in Iran,and only at the Imam Khomeini Hospital of Ahwaz and not multi center ,we do not decide to publish individual participants data ,but the results are certainly presented as an article.
public Mina Agahin
No.37,East Pahlevan Avenue ,Kian pars Town
Ahwaz Iran (Islamic Republic of) 6155683567 +98 61 3222 2043 agahin.m@ajums.ac.ir Ahvaz University of Medical Sciences scientific Mina Agahin
No 37, East pahlevan avenue, Kian Pars Town
Ahwaz Iran (Islamic Republic of) 6155683567 +98 61 3222 2043 agahin.m@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Preterm neonate with gestational age of 28-34 weeks With respiratory distress syndrome With respiratory distress syndrome score of 6-8 according to Silver man-Andersen score Entrance to study in primary 6 hours of birth 1 day 1 day Both Major congenital abnormalities Air way abnormalities Sever cardio-vascular instability Sever asphyxia(Apgar score<=3 at minute 1 and minute 5 of birth or potential hydrogen(PH) <=7/1) Dissatisfaction of parents Meconium aspiration Diaphragmatic hernia Initioation of invasive mechanical ventilation from beginning of hospitalization Gestational age <28 week or >34 week Metabolic disorder Respiratory difficulties caused by nervous system disease or muscle disease cyanotic heart disease Birth at out of hospital studied P22.0 Respiratory distress syndrome of newborn Treatment - Devices Treatment - Devices Intervention group:The first group is neonates who are under nasal continuous positive air way pressure. fabian device from switzerland country , is used to apply this method. Intervention group: In second group ,neonate are under nasal duo positive air way pressure .Fabian device from switzerland country,is used to apply this method. Non invasive ventilation failure that require intubation and mechanical ventilation during 72 hours after entrance to study. Timepoint: During the first 72 hours of admission to study. Method of measurement: The failure of treatment is considered to be when there are one or two of the following conditions.first condition included partial pressure of carbon dioxide in arterial blood >60 millimeter of mercury and potential hydrogen of arterial blood<7/2 and partial pressure of oxygen in arterial blood <50 millimeter of mercury with fraction of inspired oxygen >60% and positive end expiratory pressure >8 centimeters of water in method of nasal continuous positive air way pressure and duo pressure >15 centimeters of water and positive end expiratory pressure >8 centimeters of water and fraction of oxygen of >60% in method of nasal duo positive air way pressure .second condition included worsening of clinical conditions (increased respiratory distress by tachypnea and severe retraction of chest )or prolong apnea (apnea for more than 20 seconds )or repeated apnea for more than 2 time in 24 hours with cyanosis and bradycardi <100 beat in minute that require ventilation with bag and mask. Intra ventricular hemorrhage. Timepoint: brain ultrasound performed by the radiologist on days 1 and 3 and 7 and 14 and 28 after admission. Method of measurement: By ultrasound of the brain performed by the radiologist. Patent ductus arteriosus (A duct that establishes the connection between the pulmonary artery and the aorta that after birth,it is naturally closed and failure in this will result in patent ductus arteriosus). Timepoint: During the first 48 hours of birth or presence of clinical symptoms of patent ductus arteriosus like hearing asystolic murmur or hypotension. Method of measurement: Echocardiography is done by the pediatric cardiologist. Chronic lung disease(oxygen dependence at gestational age 36 weeks). Timepoint: Up to 36 weeks gestational age. Method of measurement: Assessment of oxygen dependence by pulse oximetry. Air leak syndroms (alveolar rupture due to severe dilation and air entrances to the pleural space). Timepoint: The length of time the patient is treated with one of two methods of nasal continuous positive air way pressure or nasal Duo positive air way pressure . Method of measurement: chest x ray. Duration of hospitalization. Timepoint: From hospitalization until discharge. Method of measurement: Based on patient records. The occurrence of death. Timepoint: During treatment with either of the two methods studied. Method of measurement: Clinical evaluation of the absence of vital signs. Apnea (Respiratory interruption that last more than 20 seconds or less than 20 seconds but with cyanosis and bradycardia less than 100 beats per minute). Timepoint: During treatment with either of the two methods studied. Method of measurement: Pulse oximetry. The number of surfactants used(A type of lipoprotein that is present in the inner wall of the alveolus .this drug used for respiratory distress syndrome) . Timepoint: First 48 hours after intervention. Method of measurement: Pulse oximetry and need to oxygen fraction>40% and positive end expiratory pressure >= 4-6 and measurement of arterial blood gases. Ahvaz University of Medical Sciences Approved 2018-08-04 Ethics Committee of Ahvaz Jundishapur University of Medical Sciences Ahvaz Jundishapur University of Medical Sciences,Esfand avenue,Golestan Bulvar Ahvaz Khouzestan Iran (Islamic Republic of)