Growth Delay, Puberty, Delayed, Thalassemia Intermedia, Thalassemia Major
Conditions
Keywords
Thalassemia, Children and adolescents, Growth development, Health Promotion, Clinical Management
Brief summary
There are nearly 300,000 patients with severe or intermediate thalassemia in China. Growth retardation is the most significant health issue for children and adolescents with transfusion-dependent thalassemia (TDT), placing a substantial economic burden on their families and a serious social strain on the labor force. Investigating the growth and development of these children and adolescents, and establishing targeted intervention plans, holds significant social value for public health practice. 1. To screen and identify pediatric patients with growth problems by conducting growth and development assessments in high-incidence areas of China, including physical development, endocrine function, nutritional status, brain function and lifestyle behaviors. 2. Implement the MENBS clinical interventions for pediatric patients with growth problems, concentrating on the following areas: * Monitor: Continuously monitor health-related indicators through regular follow-up. * Education: Provide health education to improve the cognition of patients and their families. * Nutrition: Assess patients' nutritional risks and develop personalized diet plans. * Behavior: Recommend appropriate exercise plans to promote physical development. * Support: Conduct home visits, offer free clinics and establish a support network. 3. Repeat growth assessment for pediatric patients with growth problems after 1-year clinical interventions. 4. Evaluate the effectiveness of MENBS interventions by comparing changes in growth and development indicators.
Interventions
BEHAVIORALMENBS clinical interventions
* Monitor: Continuously monitor health-related indicators through regular follow-up. * Education: Provide health education to improve cognition of patients and their families. * Nutrition: Assess patients' nutritional risks and develop personalized diet plans. * Behavior: Recommend appropriate exercise plans to promote physical development. * Support: Conduct home visits, offer free clinics and establish a support network.
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Subjects diagnosed with transfusion-dependent thalassemia (TDT) * Male or female age ≤19 years * Subjects who are willing and able to provide written informed consent
Exclusion criteria
* Subjects with clinically significant thyroid dysfunction * Subjects received allo-HSCT or gene therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone age | Up to 1 year | one age was assessed from left hand-wrist radiographs according to the Chinese Hand-Wrist Bone Development Standard (China 05). |
| Height-for-age (m) | Up to 1 yearUp to 1 year | It is assessed using the 'Growth Standard for Children under 7 Years of Age' and the 'Standard for Height Level Classification among Children and Adolescents Aged 7-18 Years' issued by the National Health Commission |
| Body mass index-for-age (BMI-for-age, kg/m^2) | Up to 1 yearUp to 1 year | It is assessed using the 'Growth Standard for Children under 7 Years of Age' and the 'Dietary Guidelines for Chinese Residents'. |
| Endocrine function | Up to 1 year | Endocrine function such as hormonal levels (IGF-1, GH, etc.) will be measured by clinical examination |
| Nutritional status | Up to 1 year | Nutritional status will be measured by clinical examination, such as concentration of Vitamin D and Zinc |
| Intelligence quotient (IQ) | Up to 1 year | IQ will be measured by scores obtained from Raven's Progressive Matrices. Raw scores are converted into percentile ranks or IQ scores based on age-group norms: * ≥95th percentile (IQ \~125+): Very high intelligence. * 75th-94th percentile (IQ \~110-124): Above average. * 25th-74th percentile (IQ \~90-109): Average range (most common). * 5th-24th percentile (IQ \~80-89): Below average. * \<5th percentile (IQ \<80): Potential intellectual disability. |
| Brain function | Up to 1 year | Brain function will be measured by Functional Near-infrared Spectroscopy (fNIRS) to record brain activations |
Countries
China
Outcome results
None listed