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NCT Number: NCT06662045

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

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.

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Key information

Conditions

Iron-deficiency Anemia Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Growth Disorders Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutritional Status Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 month–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shenzhen Pingshan District Maternity & Child Healthcare Hospital, Department of Child Healthcare

Shenzhen, China/Guangdong, 518118, China

Location status: Recruiting

Location contact

Moujinsong Project Manager

CONTACT

[email protected]

+86 13632863500

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Neurobehavioral Development Score

    Time frame: 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.

  2. Hemoglobin (Hb)

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

    To assess the severity of anemia.

  3. Serum Ferritin

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

    To evaluate the iron stores in the body

Secondary outcomes

  1. Physical Growth (Height)

    Time frame: 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.

  2. Physical Growth ( Weight)

    Time frame: 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.

  3. Physical Growth (BMI)

    Time frame: 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.

  4. Eating behavior

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Moujinsong Project Manager, M.Sc

CONTACT

[email protected]

+86 075528799171

Sponsors and collaborators

Lead sponsor

Pingshan District Maternal & Child Healthcare Hospital of Shenzhen

Other

Registry information

Official study title

Study on the Association Between Iron Deficiency Anemia and Neurobehavioral Development and Cognitive Function in Children Aged 6 to 24 Months

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 28, 2024
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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