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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects diagnosed with transfusion-dependent thalassemia (TDT)

Male or female age ≤18 years

Subjects who are willing and able to provide written informed consent

Disqualifiers

Not applicable

Trial design

Design model

Single group

Treatments tested in this trial

  • MENBS clinical interventions

    Behavioral

    * 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.

Treatment groups

369 Participants
are divided into 1 treatment group
Group A: Pediatric patients with growth problemsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Height-for-age (m)

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

Time frame
Up to 1 year
2

Body mass index-for-age (BMI-for-age, kg/m^2)

It is assessed using the 'Growth Standard for Children under 7 Years of Age' and the 'Dietary Guidelines for Chinese Residents'.

Time frame
Up to 1 year
3

Puberty status

Puberty status will be measured using by Tanner scale (TS). It is a five-stage system to assess breast development (in girls), genital development (in boys), pubic hair growth (in both sexes).

Time frame
Up to 1 year
4

Endocrine function

Endocrine function such as hormonal levels (IGF-1, GH, etc.) will be measured by clinical examination

Time frame
Up to 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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