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

Congenital Heart Defects Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06267859
• Other study ID #: No. 2 of 2023/11/7
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 8, 2023
• Est. completion date: January 30, 2034

Study information

• Verified date: February 2024
• Source: Tashkent Pediatric Medical Institute
• Contact: Shokhida T Turdieva, DSc
• Phone: +998935872570
• Email: Shohidahon69[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: January 30, 2034
• Est. primary completion date: December 30, 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Days to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Defects
• Heart Defects, Congenital
• Respiration Disorders
• Respiratory Diseases
• Respiratory Tract Diseases

Intervention

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.

Locations

Country	Name	City	State
Uzbekistan	Turdieva Shokhida Tolkunovna	Tashkent	Yunus-obad District

Sponsors (1)

Lead Sponsor	Collaborator
Tashkent Pediatric Medical Institute

Country where clinical trial is conducted

Uzbekistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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.
Primary	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