Development of Methods for Effective Treatment and Improvement of Common Somatic Diseases in Children

Based on Medical Statistical Analysis and Screening (Dispensary) Examination, Identification of the Most Common Somatic and Congenital Diseases in Children, With the Further Development of More Effective Methods of Treatment and Recovery

The goal of the clinical study is to clarify the course of common congenital, infectious, and non-infectious diseases in children living in Uzbekistan, and to develop methods for their treatment and rehabilitation.

The main questions it aims to answer:

• Analysis of common congenital diseases among children;
• Analysis of commonly diagnosed bronchopulmonary and cardiovascular diseases among children;
• Based on the results of the primary research, common diseases among children will be identified;
• Analysis of existing treatment methods and their effectiveness;
• Development of modern methods of treatment and rehabilitation of children.

Study Overview

• Status: Recruiting
• Conditions: Congenital Heart Defects; Respiratory Diseases
• Intervention / Treatment: Combination product: The use of a combination of microelements and vitamins against the background of physiotherapy

Detailed Description

Children's health is a priority in modern medicine. Some childhood diseases are most often encountered in the practice of pediatricians and family doctors. Children with these diseases need early diagnosis, treatment, and rehabilitation.

Patient selection criteria are:

• children from birth to 15 years;
• children permanently residing in the territory where the clinical examination is carried out;
• children included in the group of "frequently ill children";
• patients without severe chronic diseases.

Exclusion criteria:

• Teenagers over 15 years old;
• Patients with severe neurological and mental diseases;
• Patients with endocrinological diseases;
• Patients with long-term chronic somatic diseases;
• Children without genetic pathologies.

Clinical research methods:

• Collection of anamnestic data;
• General examination of patients (auscultation, palpation, percussion);
• If necessary: consultation with a geneticist and pediatric doctors of various specialties (cardiologist, surgeon, urologist, nephrologist, otolaryngologist, pulmonologist, immunologist, allergist)
• Standard laboratory tests (general analysis of blood, urine, feces);
• Standard biochemical studies (microelements of blood and enzymes in venous blood);
• Instrumental studies: chest X-ray, ultrasound examination of internal organs (chest and abdominal organs), computed tomography (chest and abdominal organs);
• Study of immunological status (cellular immunity, according to standard methods); Immunological research methods - flow cytometry, mIU/mL: immunogram - CD3, CD3/4, CD3/8, CD19, CD16/56, CD3/16/56, CD3/HLA-; and others;
• Study of antioxidant status (TAS, using the PSR method, mmol/L);
• Assessing the quality of life of patients (methods: PedsQLtm 4.0; HBSC, indicator: total score on the screening survey).

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Shokhida T Turdieva, DSc; Phone Number: +998935872570; Email: Shohidahon69@mail.ru
• Study Contact Backup: Name: Kholida B Abdurashidova; Phone Number: +998935092934; Email: otdel.nayka@mail.ru

Study Locations

• Uzbekistan
  • Yunus-obad District
    • Tashkent, Yunus-obad District, Uzbekistan, 100140
      • Recruiting
      • Turdieva Shokhida Tolkunovna
      • Contact: Kholida B Abdurashidova; Phone Number: +998935092934; Email: otdel.nayka@mail.ru
      • Contact: Shokhida T Turdieva, M.D., D.Sc.; Phone Number: +998935872570; Email: Shohidahon69@mail.ru
      • Sub-Investigator: Gulmira R Nasirova, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• children from birth to 15 years;
• children permanently residing in the territory where the clinical examination is carried out;
• children included in the group of "frequently ill children";
• patients without severe chronic diseases.

Exclusion Criteria:

• Teenagers over 15 years old;
• Patients with severe neurological and mental diseases;
• Patients with endocrinological diseases;
• Patients with long-term chronic somatic diseases;
• Children without genetic pathologies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: First stage; Study of children from the group of "frequently ill children", and with congenital diseases, collection of anamnesis, their examination, clinical and laboratory examination. Purpose: to identify the most frequently encountered group of diseases among children.
No Intervention: Second stage; Study the effectiveness of treatment according to approved treatment standards
No Intervention: third stage; Based on the research results, develop your treatment tactics. It is approved by the Ethics Committee for working with patients.
Experimental: fourth stage; Use your treatment tactics among a group of patients. Study the effectiveness of the proposed therapy and rehabilitation methods.	Combination product: The use of a combination of microelements and vitamins against the background of physiotherapy; If necessary, necessary microelements and vitamins will be added to the treatment process. At the same time, physiotherapeutic procedures will be added at the rehabilitation stage.
No Intervention: fifth stage; Based on the research data, clinical recommendations for doctors will be developed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Working with archival documentation.	Medical and statistical analysis of data from children's medical institutions is carried out to identify common somatic diseases in children from birth to 15 years old associated with impaired immunity. Evaluation criterion: medical archival documentation of children's clinics in the region;; statistical analysis of archival documentation on the morbidity of children (acute respiratory: acute bronchitis and acute pneumonia; cardiovascular diseases: congenital heart disease, congenital and acquired carditis).	one year
Formation of a group of patients to study immunity and the antioxidant system in venous blood.	Objective: Preparations for a clinical trial are underway. Work in progress: 400 children with diseases of the bronchopulmonary system and congenital heart defects will be selected;; preparation and submission to the Ethics Committee under the Ministry of Health of Uzbekistan of all necessary documentation for the planned clinical trial among children; Evaluation criterion: - The percentage of detection of acute bronchopulmonary and congenital heart defects in the region of residence (results of medical statistics).	one year
Clinical scientific research.	A clinical study of sick children (acute respiratory: acute bronchitis and acute pneumonia; cardiovascular diseases: congenital heart disease, congenital and acquired carditis) is being conducted to determine the presence of immunological and antioxidant blood parameters. Work in progress: Screening medical examination of children (objective examination, general blood test - ELISA method);; Examination of venous blood for indicators of immune status (extended immunogram: CD3, CD3/4, CD3/8, CD19, and others), method: flow cytometry of venous blood, mIU/mL;; the study of antioxidant status in sick children (Total antioxidant status, method: venous blood PCR, mmol/L);; publication of the research results. Evaluation criterion: opinion of reviewers and experts in this field (comparison of the results obtained by other scientists - immunological and antioxidant research); changes in immune and antioxidant status indicators in sick children to healthy peers.	five years.
Clinical trial evaluation.	The development and implementation of clinical recommendations for practicing pediatricians, pediatric pulmonologists, and cardiologists on improving children's health with acute respiratory (acute bronchitis, pneumonia) and cardiovascular (CHD, congenital and acquired carditis) diseases. Work in progress: development and implementation of clinical recommendations for pediatricians, pediatric pulmonologists, and cardiologists;; assessment of the effectiveness of clinical recommendations based on repeated laboratory tests (immunological (flow cytometry, mIU/mL) and TAS (PCR, mmol/L)), after six months of implementation of the recommendations. Evaluation criterion: opinion of reviewers and experts - review;; assessing the quality of life of patients (methods: PedsQLtm 4.0; HBSC), indicator: total score on the screening survey;; number of recurrent illnesses and complications, indicator: the number of patients as a percentage.	three years

Collaborators and Investigators

• Sponsor: Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan
• Investigators: Principal Investigator: Shokhida T Turdieva, D.Sc., Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2023
• Primary Completion (Estimated): December 30, 2033
• Study Completion (Estimated): January 30, 2034

Study Registration Dates

• First Submitted: December 20, 2023
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 16, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: children; adolescents; lung diseases; congenital malformations; heart diseases
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital; Respiratory Tract Diseases; Respiration Disorders; Physiological Effects of Drugs; Micronutrients; Vitamins
• Other Study ID Numbers: No. 2 of 2023/11/7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This clinical study aims to discover the course of common congenital, infectious, and non-infectious diseases among children living in Uzbekistan, to develop methods for their treatment and improvement. Several separate clinical studies by young scientists will be combined.
• IPD Sharing Time Frame: 2034/01/30
• IPD Sharing Access Criteria: Researchers at the Tashkent Pediatric Medical Institute.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No