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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-6
SponsorPingshan District Maternal & Child Healthcare Hospital of Shenzhen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

The study population will consist of children aged 6 to 24 months who attend children health care clinics for routine health check-ups and vaccinations. Participants will be recruited from both hospitals and community health centers within the designated region. The population will include children diagnosed with iron-deficiency anemia and non-anemic controls, providing a comparative sample. The study will aim to capture a diverse range of children from various socioeconomic backgrounds. Informed consent will be obtained from the parents or guardians before participation, and all children will meet the specified inclusion criteria for neurodevelopmental and physical growth evaluations.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 2 trial groups
Group A: Iron-Deficient Group
Group B: Control Group (Non-Anemic)

Trial outcomes

Primary outcomes

1

Neurobehavioral Development Score

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.

Time frame
Baseline assessment and follow-up at 6 months.
2

Hemoglobin (Hb)

To assess the severity of anemia.

Time frame
Blood samples will be taken at baseline and follow-up at 3 months.
3

Serum Ferritin

To evaluate the iron stores in the body

Time frame
Blood samples will be taken at baseline and follow-up at 3 months

Secondary outcomes

1

Physical Growth (Height)

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.

Time frame
Baseline assessment and follow-up at 6 months.
2

Physical Growth ( Weight)

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.

Time frame
Baseline assessment and follow-up at 6 months.
3

Physical Growth (BMI)

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.

Time frame
Baseline assessment and follow-up at 6 months.
4

Eating behavior

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.

Time frame
Collected at baseline.

Other outcomes

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