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IRCT20150423021910N6 IRCT 2020-10-18 Esfahan University of Medical Sciences Effect of Position on duration of respiratory support in Premature newborns with RDS receiving NCPAP Comparison of the Effect of Supine and Prone Position on duration of respiratory support in Premature newborns with RDS receiving NCPAP 2018-09-23 anticipated 136 Complete https://irct.ir/trial/51634 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is simple and individuals.table of random numbers use to randomization. at first one row and one column selected randomly and conflux point of row and column was consider as initial point of sampling. then top down even numbers and odd numbers accrue to case and control groups respectively.for allocation concealment 136 envelopes prepare and random numbers register .after closure of envelopes, we put those into the box.according to the order of patients one of the envelopes open and patients allocate to case or control groups. N/A Respiratory Distress Syndrom. Intervention 1: Intervention group: The newborns in case group put in prone position and only for feeding and nurse care position change to supine for maximum 15 minute. respiratory support was established with NCPAP (Bubble CPAP Infant Delivery System, Fisher & Paykel, Auckland, New Zealand); at first CDP equal to 6-8 cmH2O and Fio2=30% was administrated. In case, the newborn needed inspiratory oxygen fraction of higher than 40% to maintain oxygen saturation in the right hand at 90–95% for more than 1 hour, the newborn would receive 200 mg/kg of Crusorf per INSURE method. In case, the newborn’s need for the inspiratory oxygen fraction of higher than 40% was consistent to maintain the oxygen saturation level in an acceptable range,after 12 h from the last administration of surfactant,Crusorf (100 mg/kg) would be administered again, and as necessary,the full course of treatment (maximum 3 dose) would be observed.after stabilization under CPAP for more than 12 hour, CDP decrease every 4 hour and in the setting as CDP=4 cmH2O and FiO2<25% newborn wean from NCPAP. Intervention 2: Control group: The newborns in control group put in supine position. respiratory support was established with NCPAP (Bubble CPAP Infant Delivery System, Fisher & Paykel, Auckland, New Zealand); at first CDP equal to 6-8 cmH2O and Fio2=30% was administrated. In case, the newborn needed inspiratory oxygen fraction of higher than 40% to maintain oxygen saturation in the right hand at 90–95% for more than 1 hour, the newborn would receive 200 mg/kg of Crusorf per INSURE method. In case, the newborn’s need for the inspiratory oxygen fraction of higher than 40% was consistent to maintain the oxygen saturation level in an acceptable range,after 12 h from the last administration of surfactant,Crusorf (100 mg/kg) would be administered again, and as necessary,the full course of treatment (maximum 3 dose) would be observed.after stabilization under CPAP for more than 12 hour, CDP decrease every 4 hour and in the setting as CDP=4 cmH2O and FiO2<25% newborn wean from NCPAP. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more informations
public Behzad Barekatain
Pediatric office, Imam hosein hospital, Imam khomeini street, Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3386 8247 b_barekatain@med.mui.ac.ir Esfahan University of Medical Sciences scientific Behzad Barekatain
Pediatric office, Imam hosein hospital, Imam khomeini street, Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3386 8247 b_barekatain@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Gestational age between 30 to 34 W Affiliated from RDS Mother received one course of steroid therapy before delivery 1 day 30 days Both Lack of Congenital Heart Disease Lack of Defects interfere with specific position Lack of Perinatal Asphyxia Lack of maternal chorioamnionitis P22.0 Respiratory distress syndrome of newborn Treatment - Devices Treatment - Devices Intervention group: The newborns in case group put in prone position and only for feeding and nurse care position change to supine for maximum 15 minute. respiratory support was established with NCPAP (Bubble CPAP Infant Delivery System, Fisher & Paykel, Auckland, New Zealand); at first CDP equal to 6-8 cmH2O and Fio2=30% was administrated. In case, the newborn needed inspiratory oxygen fraction of higher than 40% to maintain oxygen saturation in the right hand at 90–95% for more than 1 hour, the newborn would receive 200 mg/kg of Crusorf per INSURE method. In case, the newborn’s need for the inspiratory oxygen fraction of higher than 40% was consistent to maintain the oxygen saturation level in an acceptable range,after 12 h from the last administration of surfactant,Crusorf (100 mg/kg) would be administered again, and as necessary,the full course of treatment (maximum 3 dose) would be observed.after stabilization under CPAP for more than 12 hour, CDP decrease every 4 hour and in the setting as CDP=4 cmH2O and FiO2<25% newborn wean from NCPAP. Control group: The newborns in control group put in supine position. respiratory support was established with NCPAP (Bubble CPAP Infant Delivery System, Fisher & Paykel, Auckland, New Zealand); at first CDP equal to 6-8 cmH2O and Fio2=30% was administrated. In case, the newborn needed inspiratory oxygen fraction of higher than 40% to maintain oxygen saturation in the right hand at 90–95% for more than 1 hour, the newborn would receive 200 mg/kg of Crusorf per INSURE method. In case, the newborn’s need for the inspiratory oxygen fraction of higher than 40% was consistent to maintain the oxygen saturation level in an acceptable range,after 12 h from the last administration of surfactant,Crusorf (100 mg/kg) would be administered again, and as necessary,the full course of treatment (maximum 3 dose) would be observed.after stabilization under CPAP for more than 12 hour, CDP decrease every 4 hour and in the setting as CDP=4 cmH2O and FiO2<25% newborn wean from NCPAP. Duration of CPAP. Timepoint: Hour. Method of measurement: Questionnaire. Mean of CPAP. Timepoint: During study. Method of measurement: CPAP desktop. Duration of hospitalization. Timepoint: Daily. Method of measurement: Questionnaire. Need for mechanical ventilation. Timepoint: During study. Method of measurement: Clinical examination. Bronchopulmonary dysplasia. Timepoint: During study. Method of measurement: Clinical examination. Pneumothorax. Timepoint: During study. Method of measurement: Chest X ray. Time to full enteral feeding. Timepoint: During study. Method of measurement: Clinical examination. The number of surfactant administration. Timepoint: During study. Method of measurement: Clinical examination. Esfahan University of Medical Sciences Approved 2017-12-04 Ethics committee of Isfahan University of Medical Sciences Hezarjerib boulevard, Isfahan University of Medical Sciense, Isfahan Isfahan Isfehan Iran (Islamic Republic of)