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

P

Pingshan District Maternal & Child Healthcare Hospital of Shenzhen

Status

Enrolling

Conditions

Growth Disorders
Nutritional Status
Iron-Deficiency Anemia
Neurobehavioral Manifestations

Study type

Observational

Funder types

Other

Identifiers

NCT06662045
20230608

Details and patient eligibility

About

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.

Enrollment

1,000 estimated patients

Sex

All

Ages

6 months to 6 years old

Volunteers

No Healthy Volunteers

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.

Trial design

1,000 participants in 2 patient groups

Iron-Deficient Group
Description:
This group consists of children diagnosed with iron-deficiency anemia.
Control Group (Non-Anemic)
Description:
This group consists of children without iron-deficiency anemia.

Trial contacts and locations

1

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Central trial contact

Moujinsong Project Manager, M.Sc

Data sourced from clinicaltrials.gov

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