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IRCT20110807007244N9 IRCT 2022-07-17 Mashhad University of Medical Sciences The effect of vitamin D injection at birth on the incidence of retinal disorder of prematur infant The effect of vitamin D injection at birth on the incidence of retinopathy of prematurity 2022-06-22 anticipated 35 Complete https://irct.ir/trial/56654 interventional Randomization: Randomized, Blinding: Triple 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, using Random Allocation Software, a block randomization list with different sizes 4 or 6 is prepared, then according to the order of the contents of the blocks, which includes the group’s name and unique identification code, each patient is assigned to one of the groups, Blinding description: By admitted of newborn, the nurs accidentally opens one of the blocks and, without knowing the grouping, presents one of the numbers to a researcher who is aware of the type of group. The researcher injects 10000 IU from ampoule of vitamin D into the newborn of the intervention group. The infant will be followed up by the principal investigator who is unaware of the type of group, of the presence or absence of respiratory problem. Data entry in SPSS is done as groups A and B, and the data analyst is unaware from the intervention or control group. 3 Vitamin D and neonatal problems. Intervention 1: Intervention group: remature infants less than 34 weeks of gestational age admitted to the Neonatal intensive care unit They will be injected once 10,000 units of vitamin D. Intervention 2: Control group: Premature infants less than 34 weeks of gestational age who have been admitted to the neonatal intensive care unit and have not received 10,000 units of vitamin D. No - There is not a plan to make this available Justification or reason for not sharing IPD is The research team has no plans to publish the IPD
public Mashhad University of Medical Sciences
NICU, Pediatrics Dep, Ghaem Hospital, ahmadabad St.
Mashhad Iran (Islamic Republic of) 91766-99199 00988412069 Boskabadih@mums.ac.ir Mashhad University of Medical Sciences scientific Boskabadi Hassan
NICU, Pediatrics Dep, Ghaem Hospital, ahmadabad St.
Mashhad Iran (Islamic Republic of) 91766-99199 00988412069 boskabadih@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Premature infants less than 34 weeks of gestational age admitted to the NICU no limit no limit Both Overt congenital anomaly Death in delivery room Infants of drug-using mothers Mothers of Asthma E55.9 Vitamin D deficiency, unspecified Prevention N/A Intervention group: remature infants less than 34 weeks of gestational age admitted to the Neonatal intensive care unit They will be injected once 10,000 units of vitamin D. Control group: Premature infants less than 34 weeks of gestational age who have been admitted to the neonatal intensive care unit and have not received 10,000 units of vitamin D. Present or unrepresented Retinopathy of prematurity. Timepoint: 4 week after births. Method of measurement: retinal exam. Mashhad University of Medical Sciences Approved 2021-09-07 Ethics committee of Mashhad university of medical sciences NICU, Ghaem Hospital,Ahmadabad ST,Mashhad,Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)