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

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

Status and phase

Invitation-only

Early Phase 1

Conditions

Congenital Heart Defects

Respiratory Diseases

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06267859

No. 2 of 2023/11/7

Details and patient eligibility

About

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.

Full 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).

Enrollment

600 estimated patients

Sex

All

Ages

3 days to 15 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

600 participants in 5 patient groups

First stage

No Intervention group

Description:

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 group

Description:

Study the effectiveness of treatment according to approved treatment standards

third stage

No Intervention group

Description:

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

fourth stage

Experimental group

Description:

Use your treatment tactics among a group of patients. Study the effectiveness of the proposed therapy and rehabilitation methods.