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IRCT20150423021910N8 IRCT 2022-02-11 Esfahan University of Medical Sciences Evaluation of appropriate for delivering positive expiratory pressure in preterm newborns affiliated from RDS Comparison the effect of nasal mask and nasal prong on duration of nasal CPAP support and other complications of prematurity in preterm newborns affiliated from RDS 2022-02-20 anticipated 196 Complete https://irct.ir/trial/61735 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 first and second groups respectively. for allocation concealment 196 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 Syndrome. Intervention 1: Intervention group: The newborns in first group put in supine position and respiratory support was established with nCPAP (Bubble CPAP Infant Delivery System, Fisher & Paykel, Auckland, New Zealand) with nasal mask; at first CDP equal to 6-8 cmH2O and Fio2=30% was administrated. If 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. If 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: Intervention group: The newborns in second group put in supine position and respiratory support was established with nCPAP (Bubble CPAP Infant Delivery System, Fisher & Paykel, Auckland, New Zealand) with nasal prong; at first CDP equal to 6-8 cmH2O and Fio2=30% was administrated. If 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. If 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
Hezarjerib boulevard, Isfahan University of Medical Scienses
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3261 6670 b_barekatain@med.mui.ac.ir Esfahan University of Medical Sciences scientific Behzad Barekatain
Hezarjerib boulevard, Isfahan University of Medical Scienses
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3261 6670 b_barekatain@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Gestational age between 28 to 34 W Affiliated from RDS Mother received one course of steroid therapy before delivery 1 day 30 days Both Existence of Congenital Heart Disease Existence of Perinatal Asphyxia(umbilical pH less than 7/2 and bicarbonate less than 12) Existence of maternal chorioamnionitis P22.0 Respiratory distress syndrome of newborn Treatment - Devices Treatment - Devices Intervention group: The newborns in first group put in supine position and respiratory support was established with nCPAP (Bubble CPAP Infant Delivery System, Fisher & Paykel, Auckland, New Zealand) with nasal mask; at first CDP equal to 6-8 cmH2O and Fio2=30% was administrated. If 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. If 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 group: The newborns in second group put in supine position and respiratory support was established with nCPAP (Bubble CPAP Infant Delivery System, Fisher & Paykel, Auckland, New Zealand) with nasal prong; at first CDP equal to 6-8 cmH2O and Fio2=30% was administrated. If 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. If 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. The number of surfactant administration. Timepoint: During study. Method of measurement: Clinical examination. Nasal trauma. Timepoint: During study. Method of measurement: Clinical examination. Esfahan University of Medical Sciences Approved 2021-08-07 Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences Hezarjerib bolvar, Isfahan University of Medical Sciense Isfahan Isfehan Iran (Islamic Republic of)