Impact of Iron Deficiency Anemia on Neurobehavioral and Cognitive Development in Children Aged 6 to 24 Months

Recruiting

• Conditions: Iron-Deficiency Anemia; Neurobehavioral Manifestations; Growth Disorders; Nutritional Status

• Registration Number: NCT06662045
• Lead Sponsor: Pingshan District Maternal & Child Healthcare Hospital of Shenzhen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-23
• Study First Submitted QC: 2024-10-25
• Last Update Submitted: 2024-10-25
• Study First Posted: 2024-10-28
• Last Update Posted: 2024-10-28
• Primary Completion: 2026-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neurobehavioral Development Score	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.
Hemoglobin (Hb)	Blood samples will be taken at baseline and follow-up at 3 months.	To assess the severity of anemia.
Serum Ferritin	Blood samples will be taken at baseline and follow-up at 3 months	To evaluate the iron stores in the body

Secondary Outcome Measures

Name	Time	Method
Physical Growth (Height)	Baseline assessment and follow-up at 6 months.	This measure evaluates the physical growth of children, specifically tracking changes in height. Growth data will be compared between children with iron-deficiency anemia and those without to assess the impact of anemia on physical development.
Physical Growth ( Weight)	Baseline assessment and follow-up at 6 months.	This measure evaluates children's changes in weight. Weight data will be compared between children with and without iron-deficiency anemia to assess anemia's impact on their physical development.
Physical Growth (BMI)	Baseline assessment and follow-up at 6 months.	This measure assesses children's physical growth by tracking changes in BMI. BMI (Body Mass Index) is calculated by dividing a child's weight (kg) by the square of their height (m²). BMI values will be compared between children with and without iron-deficiency anemia to evaluate anemia's impact on physical development.
Eating behavior	Collected at baseline.	Eating behavior was assessed using the Children's Eating Behaviour Questionnaire (CEBQ), which evaluates various aspects of children's eating habits, such as food responsiveness, enjoyment of food, and satiety responsiveness. The CEBQ scores will be compared between children with and without iron-deficiency anemia to evaluate how anemia might impact their eating behavior and, in turn, their physical development.

Trial Locations

Locations (1)

Shenzhen Pingshan District Maternity & Child Healthcare Hospital, Department of Child Healthcare; 🇨🇳 Shenzhen, China/Guangdong, China