Investigating the effect of budesonide nebulizer on healing and treatment process of children with pneumonia aged 1 month to 5 years: a randomized clinical trial

Investigating the effect of budesonide nebulizer on the recovery and treatment of children with pneumonia from 1 month to 5 years

Clinical trial with control group, with parallel groups, randomized, phase 3 on 122 patients. Random permutation method with the size of 2, 4 and 6 random blocks was used for randomization.

the trial will be conducted at Hajar Hospital in Shahrekord city.Blood sample will be taken for CBC, ESR, CRP. The PRESS score is calculated and the samples are divided into 3 groups based on the severity of pneumonia: mild, moderate and severe. PRESS score and its content, number of coughs during the day will be calculated during hospitalization. At the end of intervention, CBC, ESR, CRP will be checked again and the days of hospitalization will be recorded. the control and intervention groups then will be compared based on the severity of the disease.

Inclusion: age between 1 month and 5 years, diagnosis of community-acquired pneumonia by a pediatric specialist,complete symptoms, informed consent of the child's family to enter the study. Exclusion: presence of metabolic ,cardiopulmonary or hypersensitivity airway disease, discontinuation of standard treatment for any possible reason, children with abnormal coagulation function, psychological disorder, diabetes and immunodeficiency and unwillingness to Continue treatment

In the intervention group, a dose of 0.5 mg of Budesonide nebulizer of Pulmicort brand will be used every 12 hours for 5 days. Common interventions will be used in the control group (not receiving budesonide nebulizer).

Duration of hospitalization, duration of fever, duration of cough, duration of need for intravenous fluids, duration of wheezing, PREES score, oxygen saturation level, respiratory status and laboratory factors (WBC, ESR, CRP)

The allocation of participants into 2 groups will be done randomly and by block method. The random assignment sequence is performed using a computer program. The random permutation method with the size of random blocks 2, 4, and 6 (because the last person in each block is not known) will be used to assign people to two groups receiving medicine, including 61 people, and the control group, including 61 people.

The information obtained from the patients includes height, weight, BMI, hospitalization history, smoking and smoking in the family, urban or rural residence, and can be shared

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