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IRCT20221219056868N1 IRCT 2023-05-13 Mashhad University of Medical Sciences Study The Effect of Home-made Formulas in Children Admitted to the Intensive Care Unit Study The Effect of Enteral Nutrition with Home-made Formula Compared with Commercial Formulas on Tolerance, Blood Factors and Clinical Symptoms in Children Aged 2-18 Years Admitted to PICU 2023-05-19 anticipated 24 Complete https://irct.ir/trial/67515 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Individual-based block randomization will be used in this study. The random sequence will be generated using the website www.sealedenvelope.com and based on blocks of four locations. This step is done by the methodologist of the project and then in order to maintain the concealment of the allocation, the said sequence will be delivered to the researcher in sealed, opaque and numbered envelopes, Blinding description: The designed study is one-sided blind, in which the data analysts are blinded. In this way, the analyst did not inform the information belongs to which group (intervention or control). N/A Enteral nutrition with homemade formula. Intervention 1: Intervention group: First, the daily calorie requirement is determined using Schofield's formula, then according to the individual's needs, homemade formulas with specific formulations include 15 grams of carrots, 15 grams of broccoli, 65 grams of chicken breast, 33 grams of rice flour, 20 grams of bananas, 20 grams of apples, and 9 grams of sugar. 27 grams of powdered milk, 11 grams of olive oil and 285 milligrams of water are given. The intervention lasts 14 days. Intervention 2: Control group: In the control group, the daily calorie requirement is first determined using the Schofield formula, then according to the needs of the individual, the commercial formula of Resource Junior is given to the patient for 14 days. Yes - There is a plan to make this available What will be shared: In case of need, all data will be provided to the research vice-chancellor of Mashhad Medical Sciences in an unidentifiable manner and in compliance with all ethical standards. When: After conducting the study and defending the student thesis, the findings of the study will be published in the form of student thesis and valid articles. To whom: All researchers in the field of health are able to use the findings of this study if they obtain written permission from the vice president of research of Mashhad University of Medical Sciences and the supervisor of the project. Conditions: After obtaining permission from the Research Vice-Chancellor of Mashhad University of Medical Sciences and the main executive of the project, in order to conduct further studies in this field, the findings of this study will be available to the researchers. Where to obtain: Vice President of Research of Mashhad University of Medical Sciences, the main implementer of the project (Dr. Mohammad Safarian, Professor of Nutrition). How to obtain: Obtaining a written permission from the Research Vice-Chancellor of Mashhad University of Medical Sciences, then referring to the Faculty of Medicine of Mashhad University of Medical Sciences and obtaining permission from the main executive of the project and the director of the Nutrition Department. Comments:
public Dr Mohammad Safarian
Faculty of Medicine, Ferdowsi University Campus, East Gate, Azadi Square, Mashhad, Razavi Khorasan
masshad Iran (Islamic Republic of) 9177948564 +98 51 3800 2000 SafarianM@mums.ac.ir Mashhad University of Medical Sciences scientific Dr Mohammad Safarian
Faculty of Medicine, Ferdowsi University Campus, East Gate, Azadi Square, Mashhad, Razavi Khorasan
mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2359 SafarianM@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Parents' willingness to cooperate and sign the informed consent form ages 2-18 years hospitalization and Admitted to the PICU stable condition of the person having a NG-Tube above 12 French patients must be able to tolerate Bolus feeding 2 years 18 years Both Liver failure Renal failure Metabolic diseases include glutaric aciduria type 1 and 2, ketoadipic aciduria, isovaleric acidemia, fatty acid oxidation disorder, fructose metabolism disorder, glycogen storage disease, Pku, tyrosinemia, urea cycle disorders, homocystinuria, propionic acidemia, and methylmalonic acidemia Allergy to one of the formula ingredients Treatment - Other Treatment - Other Intervention group: First, the daily calorie requirement is determined using Schofield's formula, then according to the individual's needs, homemade formulas with specific formulations include 15 grams of carrots, 15 grams of broccoli, 65 grams of chicken breast, 33 grams of rice flour, 20 grams of bananas, 20 grams of apples, and 9 grams of sugar. 27 grams of powdered milk, 11 grams of olive oil and 285 milligrams of water are given. The intervention lasts 14 days. Control group: In the control group, the daily calorie requirement is first determined using the Schofield formula, then according to the needs of the individual, the commercial formula of Resource Junior is given to the patient for 14 days. Tolerance of enteral nutrition (gastric residual volume, diarrhea, constipation, vomiting, abdominal distention). Timepoint: Daily. Method of measurement: Standard 60 cc gavage syringe for aspiration of digestive contents. Weight. Timepoint: The beginning and end of the intervention. Method of measurement: Weighing with a digital scale with high accuracy. Subjective Global Nutrition Assessment questionnaire. Timepoint: The beginning and end of the intervention. Method of measurement: Subjective Global Nutrition Assessment questionnaire. The amount of formula received within 24 hours. Timepoint: Daily. Method of measurement: The amount of the patient received. Heal to head. Timepoint: The beginning and end of the intervention. Method of measurement: Using a standard meter. Mid arm circumference. Timepoint: The beginning and end of the intervention. Method of measurement: Using a standard meter. Number of days in hospital. Timepoint: The end of the intervention. Method of measurement: Number of days of hospitalization. Complete blood count (CBC). Timepoint: The beginning and end of the intervention. Method of measurement: Using the XN-350 device based on the electrical bioimpedance method In the central laboratory of Akbar Hospital. Urea. Timepoint: The beginning and end of the intervention. Method of measurement: with BT-3500 device and BIOMED kit based on turbidimetry and colorimetry in the laboratory of Akbar Hospital. Creatinine. Timepoint: The beginning and end of the intervention. Method of measurement: with BT-3500 device and PARS kit based on turbidimetry and colorimetry in the laboratory of Akbar Hospital. C – Reative Protein. Timepoint: The beginning and end of the intervention. Method of measurement: Using Ritonbio Analyze Sclave based on the creation of specific antibody against CRP by photometric method in the central laboratory of Akbar Hospital. Albumin. Timepoint: The beginning and end of the intervention. Method of measurement: with BT-3500 device and PARS kit based on turbidimetry and colorimetry in the laboratory of Akbar Hospital. Alanine transaminase. Timepoint: The beginning and end of the intervention. Method of measurement: with BT-3500 device and ZIST kit in the central laboratory of Akbar Hospital. Aspartate Aminotransferase. Timepoint: The beginning and end of the intervention. Method of measurement: with BT-3500 device and ZIST kit in the central laboratory of Akbar Hospital. Sodium. Timepoint: The beginning and end of the intervention. Method of measurement: Measurement of sodium by photometric method in the central laboratory of Akbar Hospital. Potassium. Timepoint: The beginning and end of the intervention. Method of measurement: Measurement of sodium by film photometry in the central laboratory of Akbar Hospital. Calcium. Timepoint: The beginning and end of the intervention. Method of measurement: with BT-3500 device and BIOMED kit based on turbidimetry and colorimetry in the laboratory of Akbar Hospital. Magnesium. Timepoint: The beginning and end of the intervention. Method of measurement: with BT-3500 device and PARS kit based on turbidimetry and colorimetry in the laboratory of Akbar Hospital. Phosphorus. Timepoint: The beginning and end of the intervention. Method of measurement: with BT-3500 device and PARS kit based on turbidimetry and colorimetry in the laboratory of Akbar Hospital. Mashhad University of Medical Sciences Approved 2022-12-25 Study The effect of enteral nutrition with home-made formula compared with commercial formulas on to Faculty of Medicine, Ferdowsi University Campus, East Gate, Azadi Square, Mashhad, Razavi Khorasan mashhad Razavi Khorasan Iran (Islamic Republic of)