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

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

A clinical trial with a control group, with parallel groups, single blind, randomized, on 24 patients Blocked randomization that used the table of random numbers from www.randomization.com.

In the Akbar Children's Hospital of Mashhad, children aged 2-18 years admitted to PICU will be examined in terms of formula tolerance, blood factors and clinical symptoms in two groups. In the control group, enteral feeding with standard commercial formulas and in the intervention group, handmade enteral nutrition with a specific formulation approved by the ethics committee is given to the patients. The study is single blind, and the analysts in this study are blinded.

Inclusion criteria: 1. Children from 2 -18 years old 2. Hospitalization in the pediatric intensive care unit of Akbar Hospital 3.stable hemodynamic conditions 4. Tolerance of bolus feeding 5. The informed consent form must be signed by the parents 6. Having a feeding tube above 12 French Exclusion criteria: 1. Suffering from liver failure 2. Suffering from kidney failure 3. Suffering from metabolic diseases 4. Being allergic to one of the formula ingredients

In the intervention group, homemade formula with a specific formulation is given, and the control group is given Resource Junior formula.

Amount of receiving formulas, symptoms of intolerance including gastric residual volume, diarrhea, constipation, vomiting, abdominal distention

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.

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).

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.

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.

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.

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.

Vice President of Research of Mashhad University of Medical Sciences, the main implementer of the project (Dr. Mohammad Safarian, Professor of Nutrition).

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.