Clinical trial NCT06267859: Development of Methods for Effective Treatment and Improvement of Common Somatic Diseases in Children
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Respiratory Diseases
Congenital Heart Defects
Keywords: children
adolescents
heart diseases
lung diseases
congenital malformations
Lead sponsor: Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 110
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: identification of children from the group of "frequently ill children"
Primary purpose: SUPPORTIVE_CARE

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.

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;
* 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Working with archival documentation.
timeFrame: one year
measure: Formation of a group of patients to study immunity and the antioxidant system in venous blood.
timeFrame: one year
measure: Clinical scientific research.
timeFrame: five years.
measure: Clinical trial evaluation.
timeFrame: three years
Secondary outcomes:
Other outcomes:
Locations:
city: Tashkent
country: Uzbekistan
facility: Turdieva Shokhida Tolkunovna
state: Yunus-obad District
Study officials:
affiliation: Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan
name: Shokhida T Turdieva, D.Sc.
role: PRINCIPAL_INVESTIGATOR
References: