An Investigation of the Effect of Using Synbiotic and Zinc in the Treatment of Admitted Children with Bacterial Pneumonia

Evaluation of the interventional effects of probiotics and zinc sulfate on clinical symptoms and duration of Hospitalization in children with bacterial pneumonia

Clinical trial study includes control and invention groups, randomized block blocking method, double blind. The sample size in each group is 45 person, and a total of 135 patients. Describe quantitative variables with mean and standard deviation and for qualitative variables with a large percentage. ANOVA tests are used to compare means.

Double-blind clinical trial. Heshmatieh hospital of Sabzevar university of medical sciences. Prescription antibiotics is the basis of treatment similarly in all three groups. Prescription age-based synbiotics Pedilact and Kidilact in the second group and zinc sulfate syrup in the third group. Blindness: The patient was randomly assigned to study in one of three groups and uninformed about the type of intervention group by treatment evaluator.

Criteria for entry: Infants and children aged 1 month to 18 years, based on clinical, radiographic, and laboratory findings, including: leukocytosis with left shifting , high erythrocyte sedimentation rate, high C-reactive protein, or pulmonary involvement in chest radiography. Criteria for no entry: The presence of underlying disease includes: cystic fibrosis, congenital heart disease, immunodeficiency, chronic pulmonary heart disease, neuro developmental delay and Failure to Thrive(FTT).

Control group: antibiotic treatment alone, Prescribing antibiotics, along with the synbiotics , Prescribing antibiotics, along with zinc sulfate syrup

Number of hospitalization days, fever, respiratory rate, retraction, crackle, wheezing, coughing, and side effects such as diarrhea at the time of entry and during days of hospitalization.

Simple randomization does not guarantee balance in numbers in the study. Especially, if patient characteristics change over time (for example, early patients are worse are after treatment) in the early imbalance can not be corrected. Randomization the block is used to solve this problem. The main idea of ​​randomized block division patients to M block 2N, so that in each block N patient A and N patient B is assigned. The block is then randomly selected. This B to The method of allocating equal treatment in each block provided that the block is fully utilized 2 × 2 = and the block size is 4 B, A, ensures, for example: two treatments assignment of treatment may be within each block (6) BAAB, (5) ABBA, (4) BABA, (3) ABAB, (1) AABB (2) BBAA The size of the block, depending on the number of treatments, should be short enough to balance prevent, and be large enough to guess the allocation of treatment in each prevent the group during the study. The size of the block should be at least 2 times the number of groups be a cure. The size of the block is not stated in the study so that researchers are blind to it. If the blocks are expressed, the therapeutic series in each block are predictable. For example, 2 N it can be inferred. This can be B as A and in B it should be A, = in block 4 This is a way to prevent this error (Selection bias) That is: 1. The mechanism of the block should not be revealed 2. The use of random block size.

This research is a double-blind clinical trial in which concealment is performed on the person allocating the treatment so that the patient is selected and the type of intervention group is determined randomly and without the knowledge of the person allocating the treatment. The person evaluating the treatment also does not know the type of drug assigned to the groups. To evaluate the outcome, patients' clinical symptoms at first entry and daily until the discharge through examination, is evaluated by a person who is not aware of the type of treatment assigned and is recorded in the relevant table.

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Dr Sara Binesh, Pediatric Assistant, Sabzevar University of Medical Sciences. Pediatric Section, Heshmatie Hospital, Asadabadi Ave., Sabzevar, Iran. Postal Code: 9613873136 Tell: 051440111606 Mobile: 09155722137 E. mail: sara76.binesh@gmail.com

Email to researcher: sara76.binesh@gmail.com Correspondence to researcher.