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Recruiting NCT06662045

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

— Observational Iron-Deficiency Anemia Neurobehavioral Manifestations Growth Disorders Nutritional Status

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Iron-Deficiency Anemia, Neurobehavioral Manifestations, Growth Disorders, Nutritional Status. Basic parameters: 6 months — 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Primary outcome measures

  • Neurobehavioral Development Score [Time frame: Baseline assessment and follow-up at 6 months.]
  • Hemoglobin (Hb) [Time frame: Blood samples will be taken at baseline and follow-up at 3 months.]
  • Serum Ferritin [Time frame: Blood samples will be taken at baseline and follow-up at 3 months]
Secondary outcome measures (4)
  • Physical Growth (Height) [Time frame: Baseline assessment and follow-up at 6 months.]
  • Physical Growth ( Weight) [Time frame: Baseline assessment and follow-up at 6 months.]
  • Physical Growth (BMI) [Time frame: Baseline assessment and follow-up at 6 months.]
  • Eating behavior [Time frame: Collected at baseline.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Shenzhen Pingshan District Maternity & Child Healthcare Hospital, Department of Child Heal — Shenzhen

Publications

  • Hanson MA, Gluckman PD. Developmental origins of health and disease--global public health implications. Best Pract Res Clin Obstet Gynaecol. 2015 Jan;29(1):24-31. doi: 10.1016/j.bpobgyn.2014.06.007. Epub 2014 Aug 19. PMID 25225058
  • Pala E, Erguven M, Guven S, Erdogan M, Balta T. Psychomotor development in children with iron deficiency and iron-deficiency anemia. Food Nutr Bull. 2010 Sep;31(3):431-5. doi: 10.1177/156482651003100305. PMID 20973463
  • Georgieff MK. Iron assessment to protect the developing brain. Am J Clin Nutr. 2017 Dec;106(Suppl 6):1588S-1593S. doi: 10.3945/ajcn.117.155846. Epub 2017 Oct 25. PMID 29070550
  • Chikani UN, Bisi-Onyemaechi A, Ohuche I, Onu J, Ugege S, Ogugua C, Mbanefo N, Chime P, Emodi I. The effect of sickle cell anemia on the linear growth of Nigerian children. J Pediatr Endocrinol Metab. 2021 Jul 19;34(10):1283-1290. doi: 10.1515/jpem-2021-0232. Print 2021 Oct 26. PMID 34271599
  • Pivina L, Semenova Y, Dosa MD, Dauletyarova M, Bjorklund G. Iron Deficiency, Cognitive Functions, and Neurobehavioral Disorders in Children. J Mol Neurosci. 2019 May;68(1):1-10. doi: 10.1007/s12031-019-01276-1. Epub 2019 Feb 18. PMID 30778834
  • Yang W, Liu B, Gao R, Snetselaar LG, Strathearn L, Bao W. Association of Anemia with Neurodevelopmental Disorders in a Nationally Representative Sample of US Children. J Pediatr. 2021 Jan;228:183-189.e2. doi: 10.1016/j.jpeds.2020.09.039. Epub 2020 Oct 7. PMID 33035572
  • Stevens GA, Finucane MM, De-Regil LM, Paciorek CJ, Flaxman SR, Branca F, Pena-Rosas JP, Bhutta ZA, Ezzati M; Nutrition Impact Model Study Group (Anaemia). Global, regional, and national trends in haemoglobin concentration and prevalence of total and severe anaemia in children and pregnant and non-pregnant women for 1995-2011: a systematic analysis of population-representative data. Lancet Glob Hea PMID 25103581

Identifiers

NCT: NCT06662045 · 20230608

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗