Study on the Association Between Iron Deficiency Anemia and Neurobehavioral Development and Cognitive Function in Children Aged 6 to 24 Months
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Hemoglobin (Hb)
研究概览
简要总结
The goal of this observational study is to explore the relationship between iron-deficiency anemia and neurobehavioral development in children aged 6-24 months. This study focuses on children who undergo health check-ups and blood tests at pediatric health clinics in Pingshan District, Shenzhen, China.
The main questions it aims to answer are:
How does iron-deficiency anemia affect children's neurobehavioral development, including motor skills, language ability, and social behavior? How does anemia influence growth and nutrition, such as weight, height, and body mass index (BMI) in children?
Participants will:
Undergo blood tests (including hemoglobin levels, serum ferritin, and serum iron) to assess anemia status.
Be assessed using the "Neuropsychological Behavioral Development Scale for Children Aged 0-6" to measure motor, cognitive, language, and social development.
Provide general health information, such as birth history, feeding methods, and parental details, through interviews with trained surveyors.
Researchers will compare children with and without iron-deficiency anemia to determine differences in neurobehavioral outcomes and development levels. The findings aim to provide evidence for early interventions to prevent the negative impacts of anemia and support children's healthy development.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6 to 24 months at the time of enrollment
- •Diagnosed with iron-deficiency anemia (for the exposure group) or confirmed
- •non-anemic status (for the control group) based on blood test results
- •Resident in the study area for at least 6 months prior to enrollment
- •Availability of parental or guardian consent to participate in the study and willingness to follow study protocols
- •Completion of all baseline assessments, including neurodevelopmental and physical growth evaluations
排除标准
- •Presence of congenital or chronic illnesses that could affect
- •neurodevelopment, such as Down syndrome or cerebral palsy.
- •History of severe infections or trauma within 3 months prior to enrollment that
- •could influence neurodevelopmental outcomes
- •Current use of medications or treatments that may interfere with iron metabolism (e.g., iron supplementation or blood transfusions in the last 6 months)
- •Premature birth (before 37 weeks of gestation) or low birth weight (< 2,500 grams)
- •Parental refusal to provide consent or non-compliance with study procedures.
结局指标
主要结局
Hemoglobin (Hb)
时间窗: Blood samples will be taken at baseline and follow-up at 3 months.
To assess the severity of anemia.
Serum Ferritin
时间窗: Blood samples will be taken at baseline and follow-up at 3 months
To evaluate the iron stores in the body
Neurobehavioral Development Score
时间窗: Baseline assessment and follow-up at 6 months.
This measure assesses neurobehavioral development, including motor skills, language, social behavior, and adaptability, using the "Neuropsychological Behavioral Development Scale for Children Aged 0-6." The score is used to determine the developmental status of children in both the iron-deficiency and non-anemic groups.
次要结局
- Physical Growth (Height)(Baseline assessment and follow-up at 6 months.)
- Physical Growth ( Weight)(Baseline assessment and follow-up at 6 months.)
- Physical Growth (BMI)(Baseline assessment and follow-up at 6 months.)
- Eating behavior(Collected at baseline.)