Clinical trial NCT06662045: Impact of Iron Deficiency Anemia on Neurobehavioral and Cognitive Development in Children Aged 6 to 24 Months
Official title: Study on the Association Between Iron Deficiency Anemia and Neurobehavioral Development and Cognitive Function in Children Aged 6 to 24 Months
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Iron-Deficiency Anemia
Neurobehavioral Manifestations
Growth Disorders
Nutritional Status
Lead sponsor: Pingshan District Maternal & Child Healthcare Hospital of Shenzhen
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Neurobehavioral Development Score
timeFrame: Baseline assessment and follow-up at 6 months.
measure: Hemoglobin (Hb)
timeFrame: Blood samples will be taken at baseline and follow-up at 3 months.
measure: Serum Ferritin
timeFrame: Blood samples will be taken at baseline and follow-up at 3 months
Secondary outcomes:
measure: Physical Growth (Height)
timeFrame: Baseline assessment and follow-up at 6 months.
measure: Physical Growth ( Weight)
timeFrame: Baseline assessment and follow-up at 6 months.
measure: Physical Growth (BMI)
timeFrame: Baseline assessment and follow-up at 6 months.
measure: Eating behavior
timeFrame: Collected at baseline.
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Pingshan District Maternity & Child Healthcare Hospital, Department of Child Healthcare
state: China/Guangdong
Study officials:
References:
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