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

August 30, 2026 updated by: Turdieva Shokhida Tolkunovna, MD, Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan

Clinical Characterization of Leading Somatic Pathologies in Pediatric Patients: Optimizing Treatment and Medical Rehabilitation Strategies

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 the most frequently diagnosed bronchopulmonary (acute bronchitis with and without obstruction, congenital pneumonia, acute and chronic pneumonia) and cardiovascular diseases in 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

Enrolling by invitation

Conditions

Intervention / Treatment

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;
  • full-term newborns with congenital pneumonia without severe complications;
  • children with acute bronchitis with airway obstruction;
  • children with acute pneumonia without complications;
  • 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);
  • Studies of enzymatic activity and protease-anti protease imbalance in children in induced bronchial fluid (TTLA, NE, MMP-8, MMP-9, CatG, CatB, CatD, CatL, AAT, A2M, SLPI, TIMP-1).
  • 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)

600

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uzbekistan
    • Yunus-obad District
      • Tashkent, Yunus-obad District, Uzbekistan, 100140
        • Turdieva Shokhida Tolkunovna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 with acute bronchitis;

  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Time Frame: one year

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.
Time Frame: one year

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.
Time Frame: five years.

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.
Time Frame: three years

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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2023

Primary Completion (Estimated)

January 30, 2032

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)

September 3, 2026

Last Update Submitted That Met QC Criteria

August 30, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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