Investigating the effect of magnesium sulfate nebulization in children with cystic fibrosis

Investigating the application of magnesium sulfate nebulization in children with cystic fibrosis

A triple blinded , randomization, phase 3 clinical trial with two arm parallel groups design of 34 patients.

During the sampling , first stage data will be collected from the patients. which includes performing a basic spirometry and completing the schwachman form. Then the desired intervention including drug and placebo will be done in each of the groups. Nebulization is performed once in the morning and once in the evening. The intervention will be continued for 4 weeks and then, spirometry will be done again and the completion of schwachman tool. Then the findings will be compared before and after.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. The place of sampling is the Cystic Fibrosis Clinic of AKBAR Hospital in mashhad, but the place of intervention is at the patient's home, along with other treatment regimens for the child.

Entry criteria: suffering from cystic fibrosis; over 6 years old; ability to perform spirometry; FEV1 above 60%. Exit criterion: non-cooperation in the continuation of the intervention; drug intolerance; nebulizer intolerance; The patient's entry into the exacerbation phase; Inability to perform spirometry.

The intervention group in the current study is all patients with cystic fibrosis who meet the inclusion criteria and receive the desired intervention in the current study, which is magnesium sulfate nebulization.

Spirometric FEV1 index; Spirometric FVC; Spirometric FEV1/FVC index; Spirometric FEF25-75 index; The score obtained from the schwachman tool

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/.

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.