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IRCT20220704055362N1 IRCT 2022-12-25 Shahid Beheshti University of Medical Sciences Effect of type of vascular access in neonatal outcomes Comparison of different strategies for vascular access in ELBW infants in NICU 2023-01-21 anticipated 183 Complete https://irct.ir/trial/67151 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The classification of the samples to be assigned to the treatment groups will be done in a block random manner. The randomization unit is considered individual. RAS statistical software, block randomization tool will also be used to determine the sequence of blocks. The sealed cover letter will be used for allocation concealment. We consider the capacity of the blocks as 6 and then we write all the possible permutations for this block, which are defined as follows. (1: ABCABC) and (2: AABBCC) and (3: BBCCAA) and (4: BACBAC) and (5: ACBBCA) and (6: BCACAB) and... By means of statistical software, we randomly select one of the numbers of permutations and consider the block corresponding to it. For example, if the first random selection of block 5 is selected, the first person will receive treatment A, the second person will receive treatment C, the third and fourth persons will receive treatment B, the fifth person will receive treatment C, and the sixth person will receive treatment A. To reach a sample size of 61 in each stratum, we continue this process 31 times. After selecting all the blocks, we randomly assign A, B, C to one of the treatment groups, Blinding description: Due to the nature of the study, blinding will only be possible for the data analysis group, and this group will not know what type of intervention groups A, B, and C have received. N/A Neonates with birth weight less than 1000 grams. Intervention 1: Intervention group: in this group Peripherally inserted Central Catheter (PICC) line will be inserted at first day of life. Intervention 2: Intervention group: In this group Umbilical Venous Catheter (UVC) will be inserted at first day of life and at day 5 to 7, UVC will be removed and Peripherally Inserted Central Catheter (PICC) will be inserted. Intervention 3: Intervention group: In this group Peripheral Inter venous (PIV) catheter will be inserted at first day of life and 5 to 7 days later PICC will be replaced. 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 more information
public Elahe Rastkar Mehrabani
Shishe Gar khaneh Alley, Fadaian Islam Ave, Shoosh Sq, Tehran, Iran
Tehran Iran (Islamic Republic of) 1185817311 +98 21 5506 2628 e.rastkar@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Ali Naseh
Shishe Gar khaneh Alley, Fadaian Islam Ave, Shoosh Sq, Tehran, Iran
Tehran Iran (Islamic Republic of) 1185817311 +98 21 5506 2628 A.naseh@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) All of neonates with birth weight less than 1000 grams who will be admitted in neonatal intensive care unit of Mahdiyeh hospital 1 day 1 day Both Congenital abnormalities Insertion of Umbilical venous catheter in delivery room in resuscitation process parents do not consent to be in this research P07.0 Extremely low birth weight newborn Treatment - Devices Treatment - Devices Treatment - Devices Intervention group: in this group Peripherally inserted Central Catheter (PICC) line will be inserted at first day of life Intervention group: In this group Umbilical Venous Catheter (UVC) will be inserted at first day of life and at day 5 to 7, UVC will be removed and Peripherally Inserted Central Catheter (PICC) will be inserted Intervention group: In this group Peripheral Inter venous (PIV) catheter will be inserted at first day of life and 5 to 7 days later PICC will be replaced Central Line Associated Blood Stream Infection. Timepoint: Since 24 hours after insertion of central line till 48 hours after removal. In this period whenever neonate has clinical signs of infection, blood culture will be sent. Method of measurement: Positive blood culture in an neonate with a central venous catheter with clinical symptoms, with no other known source of infection. Inter ventricular hemorrhage. Timepoint: Three days after birth and then weekly for a month. Method of measurement: Reviewing of brain ultrasound report. Neonatal mortality. Timepoint: From birth to 28 days old. Whenever it happens. Method of measurement: Direct observation and record in the medical record file. Shahid Beheshti University of Medical Sciences Approved 2022-11-13 Research Ethics Committees of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Me Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)