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

NCT06267859 | Recruiting Early Phase 1

• 1 other identifier: No. 2 of 2023/11/7
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Diseases; Congenital Heart Defects

Keywords

children; adolescents; heart diseases; lung diseases; congenital malformations

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (5)

First stage

NO INTERVENTION

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.

Second stage

NO INTERVENTION

Study the effectiveness of treatment according to approved treatment standards

third stage

NO INTERVENTION

Based on the research results, develop your treatment tactics. It is approved by the Ethics Committee for working with patients.

fourth stage

EXPERIMENTAL

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

fifth stage

NO INTERVENTION

Based on the research data, clinical recommendations for doctors will be developed.

Interventions

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.

fourth stage

Eligibility Criteria

• Age: 3 Days - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan: lead

Study Sites (1)

Turdieva Shokhida Tolkunovna

Tashkent, Yunus-obad District, 100140, Uzbekistan

RECRUITING

MeSH Terms

Conditions

Respiratory Tract Diseases; Heart Defects, Congenital; Heart Diseases; Lung Diseases; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Shokhida T Turdieva, D.Sc.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shokhida T Turdieva, DSc

CONTACT

+998935872570; Shohidahon69@mail.ru

Kholida B Abdurashidova

CONTACT

+998935092934; otdel.nayka@mail.ru

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: working with children from the "frequently ill children" group
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medical Sciences, Professor

Model Details: identification of children from the group of "frequently ill children"

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: February 20, 2024
• Study Start: November 8, 2023
• Primary Completion (Estimated): December 30, 2033
• Study Completion (Estimated): January 30, 2034
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2034/01/30
• Access Criteria: Researchers at the Tashkent Pediatric Medical Institute.

Locations

UZ (1)