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IRCT20110807007244N7 IRCT 2021-02-19 Mashhad University of Medical Sciences The effect of vitamin D intake in the mother during childbirth on the incidence of respiratory problems in infants The effect of vitamin D intake in the mother during childbirth on the incidence of nonspecific respiratory distress 2021-01-20 anticipated 160 Complete https://irct.ir/trial/49354 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, block randomization will be used as a reliable randomization method that leads to a balanced allocation of individuals in treatment groups at the end of each block. For this purpose, a web-based online method is used to determine the size and number of random blocks.This online software has the ability to create random blocks with variable sizes depending on the researcher. Using this website, 20 blocks with variable sizes of 6, 8 and 10 are introduced for a total of 160 samples, which are identified by numbers 1 to 20. The content of each block is proportional to the size of that block, including an equal number of intervention and control groups, with the order will be different. Following the first mother, one of the blocks is randomly selected and assigned to one of the groups based on the order of the contents of the block. Following the next mother, the next item of the same block is selected and this process continues until the first block is finished. The next block is selected randomly from the remaining blocks and the above process is repeated until sampling is completed, Blinding description: The final outcome assessor i.e the researcher who will ultimately evaluate the children in terms of the outcome of the study, is blinded of group allocations. 2-3 Non specific respiratory distress. Intervention 1: Intervention group:Pregnant mothers with a gestational age of 37-32 weeks with delivery symptoms, in four hours to three days before delivery, receive 50,000 units (one sixth of an ampoule) of injectable vitamin D, made by Caspian factory. Intervention 2: Control group: Pregnant mothers with gestational age 32-37 weeks do not receive intervention. Yes - There is a plan to make this available What will be shared: Effect of vitamin d on NRDS When: After completing the study To whom: Mashhad University of Medical Sciences Research Vice Chancellor Conditions: According to the research deputy of Mashhad University of Medical Sciences Where to obtain: Mashhad University of Medical Sciences Research Vice Chancellor How to obtain: Request of Mashhad University of Medical Sciences Research Vice Chancellor Comments:
public Hassan Boskabadi
NICU, Ghaem Hospital, Ahmadabad ST.
Mashhad Iran (Islamic Republic of) 91766-99199 098 5138787109 Boskabadih@mums.ac.ir Mashhad University of Medical Sciences scientific Hassan Boskabadi
NICU, Ghaem Hospital, Ahmadabad ST.
Mashhad Iran (Islamic Republic of) 91766-99199 098 5138412069 Boskabadih@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Pregnant woman with gestational age 32-37 weeks no limit no limit Female Congenital anomaly Congenital infection Death of newborn in the delivery room Severe asphyxia Mothers with drug abuse Respiratory distress syndrome Pneumonia Transient tachypnea of newborn Meconium aspiration syndrome P22.8 Other respiratory distress of newborn Prevention Other Intervention group:Pregnant mothers with a gestational age of 37-32 weeks with delivery symptoms, in four hours to three days before delivery, receive 50,000 units (one sixth of an ampoule) of injectable vitamin D, made by Caspian factory. Control group: Pregnant mothers with gestational age 32-37 weeks do not receive intervention. Present or absent respiratory distress. Timepoint: During the first 12 hours of birth. Method of measurement: Count the number of respiratory rate. Mashhad University of Medical Sciences Approved 2020-10-27 Ethics committee of Mashhad University of Medical Sciences Ethics committee of Mashhad University of Medical Sciences,Ghoraeshi building,Daneshgah St. Mashhad Razavi Khorasan Iran (Islamic Republic of)