Growth Evaluation, Health Promotion, and Clinical Management in Children and Adolescents With Thalassemia

Condition(s) studied

Investigational drug(s) / intervention(s)

MENBS 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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (1)

More Institute of Hematology & Blood Diseases Hospital, China trials in China