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IRCT20200616047788N1 IRCT 2020-07-21 Ahvaz University of Medical Sciences Comparing two respiratory support methods in RDS treatment of premature neonates Comparison of Continuous Positive Airway Pressure (CPAP) and Heated Humidified High Flow Nasal Cannula (HFNC) methods in treatment of neonates with respiratory distress syndrome with gestational age 28-34 weeks 2020-06-21 anticipated 120 Complete https://irct.ir/trial/49079 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Cases will be divided into 2 groups based on random block permutations. random sequences will be obtained from www.sealedenvelope.com, section: create a randomization list then the patients admitted to the NICU will be divided to A & B groups as: A,A,A,B,A,B,B,A,B,A,A,B,B. N/A neonatal respiratory distress syndrome. Intervention 1: In the CPAP group we will use Fabian CPAP PLUS ( Acutronic medical system, Switzerland) and Fisher & Paykel humidifiers (Auckland, News land). patients will receive positive end-expiratory pressure all day long until we can reduce fio2 to 30% and peep to 3 cmH2o. Intervention 2: In the HFNC group we will use Sindi 1080 (medinSINDI® medical innovations, Germany ) and Fisher & Paykel humidifiers (Auckland, News land) . patients will receive positive end-expiratory pressure all day long until we can reduce fio2 to 30% and flow to 3 lit/min. 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 no more information is available
public Mohammd Reza Aramesh
Imam Khomeini hospital
Ahvaz Iran (Islamic Republic of) 6193673166 +98 61 3222 6104 Aramesh-m@ajums.ac.ir Ahvaz University of Medical Sciences scientific Mohammad Reza Aramesh
Imam Khomeini hospital
Ahvaz Iran (Islamic Republic of) 6193673166 0986132216502 arameshmr@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) All preterm newborns with gestational age 28 -34 weeks, admitted to Imam Khomeini hospital, Ahvaz, 2020-2021 1 day 7 days Both major congenital anomaly, cyanotic congenital heart disease, neuromuscular disease, sepsis, congenital pneumonia, inborn errors of metabolism, meconium aspiration syndrome, perinatal asphyxia, APGAR score=< 5 at 5 minutes, intubation at birth or prolonged positive ventilation at the delivery room, severe RDS necessitating intubation at birth based on NRP guidelines, severe cardiovascular instability, absence of spontaneous respiration and recurrent apnea, no respiratory distress. Treatment - Devices Treatment - Devices In the CPAP group we will use Fabian CPAP PLUS ( Acutronic medical system, Switzerland) and Fisher & Paykel humidifiers (Auckland, News land). patients will receive positive end-expiratory pressure all day long until we can reduce fio2 to 30% and peep to 3 cmH2o. In the HFNC group we will use Sindi 1080 (medinSINDI® medical innovations, Germany ) and Fisher & Paykel humidifiers (Auckland, News land) . patients will receive positive end-expiratory pressure all day long until we can reduce fio2 to 30% and flow to 3 lit/min. All premature infants with RDS sore <8. Timepoint: Rds score prior and after intervention. Method of measurement: Modified Downe's scoring system. Need to intubation during first 72 hours of birth. Timepoint: third day of life. Method of measurement: physical examination, ABG, pulse oxymetry. Intraventricular hemorrhage. Timepoint: from birth to discharge if complications associated with IVH appear ( Anemia, a decrease of consciousness, change of vital signs). Method of measurement: brain sonography. Chronic lung disease. Timepoint: day 28 of life. Method of measurement: need to Fio2> 21%. Patent ductus arteriosus requiring medical treatment. Timepoint: from 3rd to 7th day of life if symptoms associated with PDA appear( need to a higher fio2 , bounding pulses). Method of measurement: echocardiography. Air leak syndromes. Timepoint: from birth until receiving CPAP or HFNC. Method of measurement: physical examination, CXR. Ahvaz University of Medical Sciences Approved 2020-06-07 Ethics committee of Ahvaz Jundishapur university of medical sciences Golestan Blvd, Ahvaz, Iran Ahvaz Khouzestan Iran (Islamic Republic of)