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IRCT20170307032933N4 IRCT 2021-06-22 Ahvaz University of Medical Sciences Effect of vitamin D in respiratory distress syndrome Evaluation of the Effectiveness of Vitamin D ŮŽAdministration in the Treatment of Preterm Neonates with Respiratory Distress Syndrome 2021-06-28 anticipated 96 Complete https://irct.ir/trial/56951 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Assignment of patients into therapeutic or control groups will be done by Block Balanced Randomization (BBR) method by using blocks with size of 6. Individuals are the randomization unit. The Randomization sequence will be generated by using the free website at http://www.randomization.com. Allocation concealment will be done by assigning unique codes, Blinding description: Parents of premature infants know that their newborns are enrolled in an investigation that is aimed to evaluate the vitamin D effect on the respiratory distress syndrome, but they are not informed that they receive placebo or vitamin D. The physician who evaluates the clinical status of patients and the nurse are not aware of the intervention that patients receive. The drug and placebo in each group are exactly in the same form and packages. The packages are distinguished only by mentioning the number and the list of numbers will be at the disposal of the statistical consultant and then the data will be analyzed. 2 Respiratory distress syndrome of newborn. Intervention 1: Intervention group 1: Daily 400 IU (1 cc) of vitamin D Drop (1000 IU, Alhavi company, Iran) for three weeks is administrated. Intervention 2: Intervention group 2: Daily 800 IU (1 cc) of vitamin D Drop (2000 IU, Alhavi company, Iran) for three weeks is administrated. Intervention 3: Control group: Daily 1 cc of placebo drop (Alhavi company, Iran) for three weeks is administrated. 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 Arash Malakian
Department of Neonatology, Imam Khomeini Hospital, Azadegan St
Ahvaz Iran (Islamic Republic of) 6135715794 0098 61 3367543 malekianarash@gmail.com Ahvaz University of Medical Sciences scientific Arash Malakian
Department of Neonatology, Imam Khomeini Hospital, Azadegan St
Ahvaz Iran (Islamic Republic of) 6135715794 0098 61 3367543 malekianarash@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Preterm newborn between 28-34 weeks gestation Preterm newborn admitted to NICU Preterm newborn with the confirmed respiratory distress syndrome based on clinical and chest X-ray findings 6 months 8 months Both Neonates with neonatal sepsis Neonates with hypoxia Neonates with congenital disorders Neonates with feeding intolerance Newborn of diabetic mother P22.0 Respiratory distress syndrome of newborn Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: Daily 400 IU (1 cc) of vitamin D Drop (1000 IU, Alhavi company, Iran) for three weeks is administrated. Intervention group 2: Daily 800 IU (1 cc) of vitamin D Drop (2000 IU, Alhavi company, Iran) for three weeks is administrated. Control group: Daily 1 cc of placebo drop (Alhavi company, Iran) for three weeks is administrated. Mortality rate. Timepoint: Within admission period. Method of measurement: Reports of nurses or physicians. Hospitalization duration. Timepoint: The first day and the last day of the patient's hospitalization. Method of measurement: Patient record. Ahvaz University of Medical Sciences Approved 2021-06-01 Research Ethics Committees of Golestan Hospital Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd Ahvaz Khouzestan Iran (Islamic Republic of)