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IRCT20190611043869N1 IRCT 2020-05-23 Sabzevar University of Medical Sciences An Investigation of the Interventional Effect of Using Probiotics and Zinc in the Treatment of Admitted Children with Bacterial Pneumonia An Investigation of the Effect of Using Synbiotic and Zinc in the Treatment of Admitted Children with Bacterial Pneumonia 2019-10-23 anticipated 135 Complete https://irct.ir/trial/40146 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Bacterial pneumonia. Intervention 1: Control group: Antibiotic treatment alone. The type of antibiotic used and the duration of treatment are determined based on the severity of the pneumonia based on the Integrated Management of Childhood Illness (IMCI) approach and Nelson 2016, and vary from a minimum of 5 to 7 days, up to a maximum of 14 days. The mentioned antibiotic treatment protocol is also implemented in the second and third intervention groups. Intervention 2: Intervention group 1: prescribing antibiotics (similar to the first group), along with the antibiotic. The type, amount, and method of use of Sinbiotic varies depending on the age of the child. PediLact oral drops for children under two years of age are used at a daily rate of 5 drops for 5 days. For children over 2 years of age, KidiLact is used daily for 1 day for 5 days, mixed with water, juice, milk or baby food, and taken 2 to 4 hours after antibiotic administration ( Water, milk or food should not be too hot). KidiLact contains high amounts of 7 strains of probiotic bacteria, including the specific probiotic strain in children "Bifido bacterium infentis", along with the prebiotic fructooligosaccharide. Intervention 3: Intervention group 2: Prescribing antibiotics (similar to the first group), along with zinc sulfate syrup. The dose is 10 mg zinc sulfate per day for children under 1 year of age and 20 mg per day for children over 1 year of age for 5 days. Yes - There is a plan to make this available What will be shared: Data Files, Statistical analysis, Article, Thesis, Questionnaires. When: No limit To whom: Students and Researchers Conditions: Submitting a letter of introduction from a university or research institute Where to obtain: 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 How to obtain: Email to researcher: sara76.binesh@gmail.com Correspondence to researcher. Comments:
public Sara Binesh
َPediatric Section, Heshmatie Hospital, Asadabadi Ave., Sabzevar, Iran.
Sabzevar Iran (Islamic Republic of) 9613873136 +98 51 4466 1777 sara76.binesh@gmail.com Sabzevar University of Medical Sciences scientific Sara Binesh
َPediatric Section, Heshmatie Hospital, Asad Abadi Ave., Sabzevar, Iran.
Sabzevar Iran (Islamic Republic of) 9613873136 +98 51 4466 1777 sara76.binesh@gmail.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) Infants and children aged 1 months up to 18 years if diagnosed on medium to very severe bacterial pneumonia Shift left-sided leukocytosis, or Erythrocyte Sedimentation Rate(ESR) and C- Reactive Protein(CRP), or pulmonary involvement in radiography (Basis of clinical, radiographic, and laboratory findings from the Integrated Management of Childhood Illness (IMCI) and Nelson 2016). 1 month 18 years Both Cystic fibrosis, maternal coronary heart disease, immunodeficiency, chronic heart disease, developmental delay, and Failure to Thrive(FTT) (weight for age below the 3rd percentile). Parental dissatisfaction J15 Bacterial pneumonia, not elsewhere classified Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: Antibiotic treatment alone. The type of antibiotic used and the duration of treatment are determined based on the severity of the pneumonia based on the Integrated Management of Childhood Illness (IMCI) approach and Nelson 2016, and vary from a minimum of 5 to 7 days, up to a maximum of 14 days. The mentioned antibiotic treatment protocol is also implemented in the second and third intervention groups. Intervention group 1: prescribing antibiotics (similar to the first group), along with the antibiotic. The type, amount, and method of use of Sinbiotic varies depending on the age of the child. PediLact oral drops for children under two years of age are used at a daily rate of 5 drops for 5 days. For children over 2 years of age, KidiLact is used daily for 1 day for 5 days, mixed with water, juice, milk or baby food, and taken 2 to 4 hours after antibiotic administration ( Water, milk or food should not be too hot). KidiLact contains high amounts of 7 strains of probiotic bacteria, including the specific probiotic strain in children "Bifido bacterium infentis", along with the prebiotic fructooligosaccharide. Intervention group 2: Prescribing antibiotics (similar to the first group), along with zinc sulfate syrup. The dose is 10 mg zinc sulfate per day for children under 1 year of age and 20 mg per day for children over 1 year of age for 5 days. Temperature. Timepoint: Daily during Hospitalization. Method of measurement: Thermometer. Respiration Rate. Timepoint: Daily during Hospitalization. Method of measurement: Cornometer. Cough. Timepoint: Daily during hospitalization. Method of measurement: Physical Examination. Crackle. Timepoint: Daily during hospitalization. Method of measurement: Physical Examination. Wheezing. Timepoint: ِِDaily during hospitalization. Method of measurement: Physical Examination. Tachypnea. Timepoint: Daily during hospitalization. Method of measurement: Physical Examination. Subcostal, Intercostal, Suprasternal Retraction. Timepoint: Daily during Hospitalization. Method of measurement: Physical Examination. Nasal Flaring. Timepoint: Daily during hospitalization. Method of measurement: Physical Examination. Diarrhea. Timepoint: Daily during hospitalization. Method of measurement: Observation. Sabzevar University of Medical Sciences Approved 2019-09-24 Ethics committee of Sabzevar University of Medical Sciences Sabzevar University of Medical Sciences. Asadabadi Ave., Sabzevar, Iran Sabzevar Razavi Khorasan Iran (Islamic Republic of)