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IRCT20231001059581N1 IRCT 2023-10-19 Ghoum University of Medical Sciences A comparative study of the response to Heated and Humidified High Flow Nasal Cannula treatment with Continuous Positive Airway Pressure method in premature infants with respiratory distress syndrome A comparative study of the response to Heated and Humidified High Flow Nasal Cannula treatment with Continuous Positive Airway Pressure method in premature infants with respiratory distress syndrome admitted to Qom Khairin Salamat Hospital 2023-10-23 anticipated 60 Complete https://irct.ir/trial/72924 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To randomize people in two groups, permuted block randomization method of 4 is used. Considering two groups A and B, the randomization process will be as follows. The entire randomization file is available as an Excel file (randomization was done with SAS software version 9) Seed: 64404995453716 Block sizes: 4 Actual list length: 60 block identifier, block size, sequence within block, treatment • 1, 4, 1, Group B In this method, group A will receive HHHFNC treatment and group B will receive CPAP treatment. For example, the first neonate born will be placed in block number one, and according to the block sequence, it will sit in position number one, and according to the random data of the software will receive treatment B The first number is the block number, the second number is the block size and the third number is the block sequence. N/A Respiratory Distress Syndrome In Newborn. Intervention 1: First Intervention group: Neonate In The First Group Receive Oxygen With A Continuous Pressure Of 5 To 6 Cm Of Water And A Flow Rate Of 8 To 10 By CPAP. Intervention 2: The Second Intervention group: In This Group, Neonate Receive Air With A Temperature Of 37 Degrees And Humidified With An Average Volume Of 2750 cc Per Minute (Neonate Weighing Less Than 1000 Grams Will Receive 2500 cc Of Air Per Minute And Neonate Weighing More Than 1000 Grams Will Receive 3000 cc Of Air Per Minute). 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 There Is No Further Information
public Alireza Saadati
Imam KhomeniSt ,Qom
Qom Iran (Islamic Republic of) 3713649373 +98 25 3162 5100 asaadati@muq.ac.ir Ghoum University of Medical Sciences scientific Alireza Saadati
Imam KhomeniSt ,Qom
Qom Iran (Islamic Republic of) 3713649373 +98 25 3162 5100 asaadati@muq.ac.ir Ghoum University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) RDS 4-6 Clinical sign Of RDS Gestational Age Between 28 To 32 Weight Less Than 1500g 1 day 28 days Both Major Congenital Anomaly Asphyxia Sign Cyanotic Heart Disease Emergency Intubation P22.0 Respiratory distress syndrome of newborn Treatment - Devices Treatment - Devices First Intervention group: Neonate In The First Group Receive Oxygen With A Continuous Pressure Of 5 To 6 Cm Of Water And A Flow Rate Of 8 To 10 By CPAP. The Second Intervention group: In This Group, Neonate Receive Air With A Temperature Of 37 Degrees And Humidified With An Average Volume Of 2750 cc Per Minute (Neonate Weighing Less Than 1000 Grams Will Receive 2500 cc Of Air Per Minute And Neonate Weighing More Than 1000 Grams Will Receive 3000 cc Of Air Per Minute). RDS Score. Timepoint: From the beginning of the study, Every 4 hours until treatment or failure. Method of measurement: Downs scale Score. Need for intubation. Timepoint: Every 4 hours based on RDS score until treatment or failure. Method of measurement: Clinical examination, RDS score. Treatment duration. Timepoint: Every 4 hours based on RDS score until treatment or failure. Method of measurement: Day. Ghoum University of Medical Sciences Approved 2023-09-11 Research Ethics Committees of Qom University of Medical Sciences No. 83, Lotfi Alley, Jahad Daneshghahi St., Safashahr St, Qom, Iran Qom Ghoum Iran (Islamic Republic of)