Investigating the effectiveness of 7% plus hypertonic saline compared to 7%hypertonic saline in reducing the growth of Pseudomonas in the lungs of cystic fibrosis patients

Determining the effectiveness of 7% hypertonic saline plus compared to 7% hypertonic saline in reducing the growth of Pseudomonas in the lungs of cystic fibrosis patients

A randomized, double-blind, parallel-group, controlled clinical trial study was conducted on 64 cystic fibrosis patients, using random allocation software for randomization.

The location of the study and clinical trial is in the clinic of Akbar Children's Hospital in Mashhad. Patients with cystic fibrosis will be divided into two intervention and control groups. All patients will have their sputum cultured for Pseudomonas aeruginosa colony count and spirometry performed before medication is prescribed. In this study, random assignment has been performed and it is single-blind (assessor). First, the ethical consent form is completed by the children's parents. After filling out the questionnaire, the child's body mass index and spirometry results are calculated and entered into the study.

Inclusion criteria: Presence of cystic fibrosis, ability to expectorate sputum, stable disease (not in exacerbation), forced expiratory volume in one second greater than 50%. Exclusion criteria: Hyperreactive pulmonary disease, oxygen saturation less than 94% on room air or with supplemental oxygen, use of intravenous antibiotics within the previous 4 weeks.

the patients in the intervention group received hypertonic saline 7 % for 3 months, which is produced by Samen company, Mashhad, for 3 months. Patients in the control group receive 4 cc of 7% hypertonic saline nebulizer which is produced by Samen company, mashhad, every 12 hours for 3 months.

Pseudomonas aeruginosa colony count growth rate in patients' sputum, forced expiratory volume in 1 second, forced vital capacity, body mass index

In this study, the block method will be used to generate the sequence of random allocation of individuals to the study groups. The sequence of random allocation of individuals will be done using Random Allocation Software and a block size of 4.

1. Blinding of participants - Both types of saline (7% regular and 7% plus) are provided in identical containers (same brand, color, shape, and packaging). - Labels are marked only with random codes (e.g., A or B) and do not indicate the type of drug. - If the drugs have a different taste or smell, a neutral flavoring or color is used so that they are not distinguishable. 2. Blinding of investigators (drug prescribing team) - The research team does not have access to the randomization list (this list is managed by a pharmacist or a central system outside the team). - The drugs are pre-coded, and the investigator only gives the code (e.g., vial “A”) to the patient without knowing the contents. - In the event of adverse events, reports are recorded without specifying the treatment group. 3. Blinding of outcome assessors (data analysis team) - Samples (e.g., sputum cultures) are sent to the laboratory with numerical codes (not A/B). - Assessors do not know which treatment group each sample belongs to.

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