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

Официальное название

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

Обзор

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.

Первичные конечные точки

• Neurobehavioral Development Score [Срок оценки: Baseline assessment and follow-up at 6 months.]
• Hemoglobin (Hb) [Срок оценки: Blood samples will be taken at baseline and follow-up at 3 months.]
• Serum Ferritin [Срок оценки: Blood samples will be taken at baseline and follow-up at 3 months]

Вторичные конечные точки (4)

• Physical Growth (Height) [Срок оценки: Baseline assessment and follow-up at 6 months.]
• Physical Growth ( Weight) [Срок оценки: Baseline assessment and follow-up at 6 months.]
• Physical Growth (BMI) [Срок оценки: Baseline assessment and follow-up at 6 months.]
• Eating behavior [Срок оценки: Collected at baseline.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Shenzhen Pingshan District Maternity & Child Healthcare Hospital, Department of Child Heal — Шэньчжэнь

Публикации

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• 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

Идентификаторы

NCT: NCT06662045 · 20230608

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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