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IRCT138810012420N2 IRCT 2010-02-10 Vice chancellor for research, Iran University of Medical Sciences and Health Services The effect of N-acetylcystein in outcome and adverse effects of intubation in neonates N-acetylcysteine for endotracheal tube patency in neonates: A randomized clinical trial 2003-03-20 anticipated 65 Complete https://irct.ir/trial/2135 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive. N/A Respiratoty Distress Syndrome of neonates. Intervention 1: cleaning of the endotracheal tube every 6 hours with 2 mililiter of N-acetylsucteine solution. Intervention 2: cleaning of the endotracheal tube every 6 hours with 2 mililiter of normal saline solution.
public Seyyed Mohammad Fereshteh Nejad
Hemmat highway
Tehran Iran (Islamic Republic of) +98 21 2275 6035 mohammad@stu.iums.ac.ir ; sfm681@yahoo.com Iran University of Medical Sciences and Health Servuces scientific Parisa Mohagheghi
Rasoul Akram Hospital, Niayesh street, Sattarkhan avenue
Tehran Iran (Islamic Republic of) pmohagh@yahoo.com Rasoul Akram Hospital Iran (Islamic Republic of) Inclusion Criteria: Neovates > 1200 gram hospitalized in NICU of Rasoul Akram hospital and needed to be intubated and mechanically ventilated based on standard protocols. Exclusion Criteria: Neonates with major anomalies or cyanotic cardiac diseases, neonates who ere intubated at the beginning of their hospitalization, neonates with pneumothorax at the time of hospitalization or intubation, massive hemorrhage, neonates who were extubated before 24 hours or dead before this time no limit 1 year Both P22.0 Respiratory distress syndrome of newborn Other Placebo cleaning of the endotracheal tube every 6 hours with 2 mililiter of N-acetylsucteine solution cleaning of the endotracheal tube every 6 hours with 2 mililiter of normal saline solution The duration of first intubation until exchange of endotracheal tube due to mucus plug retention. Timepoint: every 6 hours. Method of measurement: Tube cleaning with drugs in order to make sure that it's open. Number of endotracheal tube obstruction and replacement due to mucus plug. Timepoint: every 6 hours. Method of measurement: cleaning of the endotracheak tube to make sure that it's open. Duration of intubation. Timepoint: every day. Method of measurement: observation. Events those may be related to the new drug including apnoea and bradycardia, hypotension, pulmonary haemorrhage. Timepoint: every 6 hours. Method of measurement: monitoring of the patient. Death. Timepoint: every 6 hours. Method of measurement: control of vital signs. Vice chancellor for research, Iran University of Medical Sciences and Health Services Approved 2006-07-10 Ethics Committee of Iran University of Medical Sciences and Health services Iran University of Medical Sciences and Health services, Hemmat highway Tehran Iran (Islamic Republic of)