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NCT Number: NCT06267859

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

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.

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Key information

Age range

3 day–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The use of a combination of microelements and vitamins against the background of physiotherapy

Combination Product

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.

Primary outcomes

  1. 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).
  2. 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).
  3. 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.
  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kholida B Abdurashidova

CONTACT

[email protected]

+998935092934

Shokhida T Turdieva, DSc

CONTACT

[email protected]

+998935872570

Sponsors and collaborators

Lead sponsor

Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2033
Study completion
2034
First posted
Feb 20, 2024
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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