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IRCT20160102025811N5 IRCT 2021-04-05 Tabriz University of Medical Sciences weaning nasal continuous positive airway pressure (NCPAP) in premature neonates with respiratory distress syndrome Investigate various strategies for weaning nasal continuous positive airway pressure (NCPAP) in premature neonates with respiratory distress syndrome 2019-03-21 anticipated 90 Complete https://irct.ir/trial/43081 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, clinical trials of premature infants 26 to 32 weeks and six days of age with respiratory distress syndrome were born at the Al-Zahra Educational and Medical Center in Tabriz with respiratory shockorder (ACORN) 5 to 8%. They were airborne (NCPAP) (after the acute phase of the primary disease and the start of weaning with the approval of neonatal subspecialty or neonatal subspecialty assistant), the study entered and the infants were randomly divided into 3 groups by computer guidance. 3 Respiratory distress syndrome. Intervention 1: Premature infants 26 to 32 weeks with respiratory distress syndrome, with a positive airway end pressure of 5 and an fraction of inspired oxygen of 30%, Infants underwent respiratory support with a high flow nasal cannula at a rate of 3 liters per minute and an fraction of inspired oxygen of 30%. Intervention 2: Premature infants 26 to 32 weeks with respiratory distress syndrome, with a positive airway end pressure of 3 and an fraction of inspired oxygen of 25%, Infants underwent respiratory support with a high flow nasal cannula at a rate of 3 liters per minute and an fraction of inspired oxygen of 25%. Intervention 3: Premature infants 26 to 32 weeks with Respiratory Distress Syndrome who gradually decreased 1 cm/H2O of positive airway pressure (PEEP) every 8 hours and when reached 3 cm/H2O positive airway pressure and fraction of inspired oxygen 25% ,infants will be located in oxygen hood with 5-6 liters per minute and fraction of inspired oxygen 30%. Intervention 4: Premature infants 26 to 32 weeks with Respiratory Distress Syndrome who gradually decreased 1 cm/H2O of positive airway pressure (PEEP) every 8 hours and when reached 3 cm/H2O positive airway pressure and fraction of inspired oxygen 25% , ventilation support will be cessated and infants will be located in room air. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is We are working on it.
public Mirhadi Mousavi
Golgasht Street
Tabriz Iran (Islamic Republic of) 5136735886 +98 41 3327 2094 drmussavihadi@yahoo.com Tabriz University of Medical Sciences scientific Mirhadi Mousavi
Golgasht Street
Tabriz Iran (Islamic Republic of) 5136735886 +98 41 3327 2094 drmussavihadi@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Premature infants 26 to 32 weeks and six days with respiratory distress syndrome (premature onset of respiratory distress in the first 4 hours of life or radiographic findings in favor of respiratory distress syndrome) Positive airway pressure has been implicated in neonatal intensive care unit (NICU). 104 days 224 days Both Infants with chromosomal defects Infants with severe congenital anomalies or severe congenital heart disease Infants with sphincter with Apgar less than 7 minutes Infants under mechanical ventilation Revived (advanced) babies Babies with parental dissatisfaction with entering the study P22.0 Respiratory distress syndrome of newborn Treatment - Devices Treatment - Devices Treatment - Devices Treatment - Devices Premature infants 26 to 32 weeks with respiratory distress syndrome, with a positive airway end pressure of 5 and an fraction of inspired oxygen of 30%, Infants underwent respiratory support with a high flow nasal cannula at a rate of 3 liters per minute and an fraction of inspired oxygen of 30%. Premature infants 26 to 32 weeks with respiratory distress syndrome, with a positive airway end pressure of 3 and an fraction of inspired oxygen of 25%, Infants underwent respiratory support with a high flow nasal cannula at a rate of 3 liters per minute and an fraction of inspired oxygen of 25%. Premature infants 26 to 32 weeks with Respiratory Distress Syndrome who gradually decreased 1 cm/H2O of positive airway pressure (PEEP) every 8 hours and when reached 3 cm/H2O positive airway pressure and fraction of inspired oxygen 25% ,infants will be located in oxygen hood with 5-6 liters per minute and fraction of inspired oxygen 30%. Premature infants 26 to 32 weeks with Respiratory Distress Syndrome who gradually decreased 1 cm/H2O of positive airway pressure (PEEP) every 8 hours and when reached 3 cm/H2O positive airway pressure and fraction of inspired oxygen 25% , ventilation support will be cessated and infants will be located in room air. Respiratory distress syndrome score. Timepoint: Prior to intervention in all study groups and daily at specified times until discontinuation of respiratory support. Method of measurement: Score based on the number of breaths, need for oxygen, retraction, moaning, breathing sounds , immaturity. Apnea. Timepoint: Before the intervention and at certain times daily after the intervention until the cessation of respiratory support. Method of measurement: Number of respiratory arrests per hour. Duration of hospitalization. Timepoint: From the beginning to the end of the patient's hospitalization. Method of measurement: Number of days spent in the hospital. Need to oxygen therapy. Timepoint: Before intervention and daily at specified times until discontinuation of respiratory support. Method of measurement: 10% increase in fraction of inspired oxygen(yes/no). Retinopathy of Prematurity. Timepoint: At 28 days of birth. Method of measurement: Ophthalmological consultation. Intraventricular haemorhage. Timepoint: At the end of intervention. Method of measurement: Brain sonography. Respiratory Distress Syndrome. Timepoint: at the end of intervention. Method of measurement: Need oxygen after discharge. Mortallity. Timepoint: At the end of intervention. Method of measurement: Neonate death. Tabriz University of Medical Sciences Approved 2019-03-27 Ethics committee of Tabriz University of Medical Sciences Av.Azadi, Av.Golgasht Tabriz East Azarbaijan Iran (Islamic Republic of)