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IRCT20231031059919N1 IRCT 2024-01-08 Mashhad University of Medical Sciences Investigating the effect of magnesium sulfate nebulization in children with cystic fibrosis Investigating the effect of magnesium sulfate nebulization in children with cystic fibrosis 2023-12-22 anticipated 34 Complete https://irct.ir/trial/73778 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the current study, sampling will be done using the available method. Allocation of research units to control and intervention groups is done by randomization and block method. The purpose of adopting this method is to avoid significant imbalances in the number of participants assigned to each group. Block randomization guarantees that there is no significant imbalance between the groups at any time during the randomization, and at certain points the number of participants in each group is equal. . Then the list of possible blocks is written including AABB(1)- ABAB(2)-ABBA(3)-BBAA(4)- BABA(5)- BAAB(6)) and includes 6 possible blocks. At the time of sampling, between the numbers 1 to 6, which are the numbers of the blocks, a simple lottery will be done by chance, and 4 random samplings will be done based on the block numbers obtained from the lottery. This method will be repeated until the sample volume is completed. Randomization will be done using https://www.randomizer.org/, Blinding description: In order to comply with the principle of blinding, the study of the control group was carried out with a placebo (normal saline, which is provided to the parents of the control group in packages with the same shape as the vial of magnesium sulfate or the same drug with a different label A or B) in the same order as in the case of the control group. It was said that the intervention will be implemented. 3 Cystic fibrosis. Intervention 1: Intervention group: Cystic fibrosis patients who meet the inclusion criteria. During the sampling, first stage data will be collected from the patients. which includes performing a basic spirometry and completing the Shuvak Man form. Then the desired intervention including medicine will be carried out. The intervention includes the drug magnesium sulfate in the amount of 0.75 cc. The intervention will continue for 4 weeks and after 4 weeks, spirometry will be done again and the completion of the Shavach Man tool. Then the findings in the two groups will be compared before and after. Before and at the end of the intervention (one month after the start of the intervention), the magnesium blood level of children in the intervention and control groups will be measured. During the daily intervention period, children are followed up in terms of cardio-respiratory symptoms, nerve reflexes, vital signs and any symptoms of drug allergy or poisoning. Intervention 2: Control group: patients with cystic fibrosis who meet the inclusion criteria. During the sampling from each of the intervention and control groups, first stage data will be collected from the patients. which includes performing a basic spirometry and completing the Shuvak Man form. Then the desired intervention will be carried out including medication. The placebo intervention is normal saline in the amount of 0.75 cc, and after 4 weeks, spirometry will be done again and the completion of the Shuvach instrument. Then the findings in the two groups will be compared before and after. Before and at the end of the intervention. The magnesium blood level of children in two intervention and control groups is measured. In case of any problem, the drug will be stopped immediately and the patient's safety protocol will be followed. 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 Mitra Zibaei
Qurashi Building, next to Hoize Cinema,University St
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 3841 1538 mitrazibaei@gmail.com Mashhad University of Medical Sciences scientific Mitra Zibaei
Qurashi Building, next to Hoize Cinema, Daneshgah St.
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 3841 1538 mitrazibaei@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Suffering from cystic fibrosis Over 6 years old Ability to perform spirometry FEV1 above 60% 6 years no limit Both Nnon-cooperation in the continuation of the intervention Drug intolerance Nebulizer intolerance The patient's entry into the exacerbation phase Inability to perform spirometry E84.0 Cystic fibrosis with pulmonary manifestations Treatment - Drugs Treatment - Drugs Intervention group: Cystic fibrosis patients who meet the inclusion criteria. During the sampling, first stage data will be collected from the patients. which includes performing a basic spirometry and completing the Shuvak Man form. Then the desired intervention including medicine will be carried out. The intervention includes the drug magnesium sulfate in the amount of 0.75 cc. The intervention will continue for 4 weeks and after 4 weeks, spirometry will be done again and the completion of the Shavach Man tool. Then the findings in the two groups will be compared before and after. Before and at the end of the intervention (one month after the start of the intervention), the magnesium blood level of children in the intervention and control groups will be measured. During the daily intervention period, children are followed up in terms of cardio-respiratory symptoms, nerve reflexes, vital signs and any symptoms of drug allergy or poisoning. Control group: patients with cystic fibrosis who meet the inclusion criteria. During the sampling from each of the intervention and control groups, first stage data will be collected from the patients. which includes performing a basic spirometry and completing the Shuvak Man form. Then the desired intervention will be carried out including medication. The placebo intervention is normal saline in the amount of 0.75 cc, and after 4 weeks, spirometry will be done again and the completion of the Shuvach instrument. Then the findings in the two groups will be compared before and after. Before and at the end of the intervention. The magnesium blood level of children in two intervention and control groups is measured. In case of any problem, the drug will be stopped immediately and the patient's safety protocol will be followed. FEV1 index of spirometry in children with cystic fibrosis. Timepoint: At the beginning of the intervention and after 4 weeks at the end of the intervention. Method of measurement: Spirometry. Spirometric FVC index in children with cystic fibrosis. Timepoint: At the beginning of the intervention and after 4 weeks at the end of the intervention. Method of measurement: Spirometry. Spirometric FEV1/FVC index in children with cystic fibrosis. Timepoint: At the beginning of the intervention and after 4 weeks at the end of the intervention. Method of measurement: Spirometry. Spirometric FEF25-75 index in children with cystic fibrosis. Timepoint: At the beginning of the intervention and after 4 weeks at the end of the intervention. Method of measurement: Spirometry. The score obtained from the Schwach-Man instrument in children with cystic fibrosis. Timepoint: At the beginning of the intervention and after 4 weeks at the end of the intervention. Method of measurement: Spirometry. . Timepoint: . Method of measurement: . Mashhad University of Medical Sciences Approved 2023-10-08 Mashhad University of Medical Sciences Ethics Committee Mashhad University of Medical Sciences, Daneshgah St. Mashhad Razavi Khorasan Iran (Islamic Republic of)