Impact of Iron Deficiency Anemia on Neurobehavioral and Cognitive Development in Children Aged 6 … (NCT06662045) | Clinical Trial Compass
RecruitingNot Applicable
Impact of Iron Deficiency Anemia on Neurobehavioral and Cognitive Development in Children Aged 6 to 24 Months
China1,000 participantsStarted 2024-01-01
Plain-language 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.
Who can participate
Age range
6 Months – 6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Neurobehavioral Development Score
Timeframe: Baseline assessment and follow-up at 6 months.
2
Hemoglobin (Hb)
Timeframe: Blood samples will be taken at baseline and follow-up at 3 months.
3
Serum Ferritin
Timeframe: Blood samples will be taken at baseline and follow-up at 3 months
Trial details
NCT IDNCT06662045
SponsorPingshan District Maternal & Child Healthcare Hospital of Shenzhen