Long Term Effect of Early Iron Supplementation and Psychosocial Stimulation on Growth and Development of Iron-deficient Anaemic Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 349
- 主要终点
- Cognitive ability
研究概览
简要总结
- Burden: Anaemia is a public health problem in our country. Fifty one percent young children aged 6 to 59 months are suffering from anaemia in Bangladesh (BDHS-2011) and the main cause of this problem is iron deficiency. Research findings show that Iron deficiency leads to delayed development and even reduce working capacity. All these impact negatively on quality of life and loss of national gross domestic product (GDP).
- Knowledge gap: Little is known about long-term effects of early life iron deficiency anemia on development and behaviour of children after correction with iron supplements. There is also scarcity of information if early life psychosocial stimulation added to iron supplementation to these anemic children have long term benefits compared to non-stimulated anaemic children or non-anaemic children
- Relevance:
The aim was to conduct a follow up study to examine whether the IDA children, who recovered from iron deficiency and received additional more intense psychosocial intervention catch up to their optimum development in later life at school age, similar like non-anaemic peers. 4. Hypothesis (if any):
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The benefit of early iron supplementation in addition to Psychosocial stimulation on growth and development of IDA infants appears in later life.
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Addition of early psychosocial stimulation in treated IDA children help them catch up to their non-anemic peers in development over time.
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Study Objective(s)
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To determine the long term effect of early psychosocial stimulation provided at the age of 6-24 months in addition to iron treatment in IDA children on their growth (height, weight and Head Circumference), IQ, executive function, school achievement, fine motor, memory and behaviour
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To compare the growth and development of IDA infants with non-anemic infants after 7 years of an intervention with iron supplementation and psychosocial stimulation.
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Methods:
Sample: All children who participated in the iron and stimulation study at the age of 6 to 24 months (n=424).
Identification of sample: Using the addresses and by tracking through available mobile phone numbers.
Measurements
In the current follow-up, at the age of around 8-9 years all the available children will be measured for:
- WASI: The Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II)
- School achievement
- Number Stroop
- SDQ (strength and difficulties):The Strengths and Difficulties Questionnaire (SDQ)
- Memory test of NEPSY (neuropsychological test)
- Digit span forward and backward
- Middle childhood HOME
- Fine motor skills using the Purdue peg board or Movement Assessment Battery Children- 2 (age -band 2 for 7-10 years)
- SES Anthropometric measurement: Children's height, weight and head circumference
详细描述
Millions of young children in developing countries have developmental deficits due to some preventable factors like poor nutrition, lack of a stimulating environment, and poverty. Although Bangladesh is doing well in achieving MDGs, still poor nutrition, poverty and poor parental education are prevalent. These mutually exclusive factors have an implication not only for the individuals' future but also for national income and development.
Usually, iron deficiency in the neonatal period and early childhood is considered a key to the development of disturbances in cognitive development. There is increasing evidence that iron deficiency anemia detrimentally affects children's development. Many cross sectional studies have shown that iron deficiency is associated with poor psycho motor development and behavioral deficits in young children, and poor cognition and school achievement in school-aged children. However, anemia is associated with many adverse social and economic family circumstances which may adversely affect children's development.
Nutrition along with early child development interventions can have additive or synergistic effects on child development, and in some cases, nutritional outcomes. Meta analysis, studies conducted in low, middle and high income countries in randomized controlled trials among primary school aged children (5-12 years) showed that concurrent iron supplementation improved global cognitive scores and growth and reduced risk of anemia and iron deficiency among anemic children by 50% and 75% respectively. According to the Lancet reviews on child development iron deficiency anemia during early childhood, when brain growth spurt occurs is one of the identified risk factor for later development. Similarly early psycho social stimulation acts as a protective factor in optimizing later development. Studies in Indonesia and Canada both found benefits from iron treatment to infants' motor development but not to mental development. It has been suggested that the poor level of mental development found in IDA infants may be irreversible in some circumstances. One systematic review and meta analysis revealed that daily iron supplementation in 2 to 5 years children increases hemoglobin and ferretin but has limited evidence in cognitive development and physical growth..
Anemia is a public health problem in Bangladesh where 51% of young children aged 6 to 59 months are suffering and the main cause of this problem is iron deficiency. A study conducted in Bangladesh found a non significant benefit to motor development from iron alone however the power of the study was extremely limited and the group receiving iron and zinc benefited in motor development. We also conducted a cluster randomized controlled trial in 2007-2008 on 6-24 months old iron deficient anemic (IDA) and non- anemic non-iron deficient (NANI) children with iron supplementation to IDA children for 6 months and weekly psycho social stimulation to all children in the stimulation clusters for 9 months in Bangladesh. The result showed that although the intervened IDA group recovered from their iron deficient status after 9 months, hey had significantly lower psycho motor development index (PDI) and responsiveness to the examiner compared to NANI group. Random-effects multilevel regressions of the developmental scores showed that psycho social stimulation improved children's mental development Index (MDI) in both the group. Interaction between iron status and stimulation showed a suggestive trend indicating that children with IDA and NANI responded differently to stimulation, i.e. the IDA group improved less than the NANI group. During that time we predicted that benefit of Iron supplementation and psycho social stimulation on children may appear in later life with application of more sensitive measurement tools for intelligence. The present study provides us a unique opportunity to examine long term effect of early iron supplementation and psycho social stimulation on growth and development of iron deficient anemic children.
Hypothesis:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 9 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All non anaemic children
- •Anaemic children (Haemoglobin concentration .80g/L and ,110g/L) and
- •Serum transferrin receptor concentration ≥ 5.0mg/L
排除标准
- •Twin Baby
- •Children with known hematological diseases
- •Children with known chronic diseases
- •Refused concent
结局指标
主要结局
Cognitive ability
时间窗: single time point at follow up after an average of 6 years of the original study
We will use The Wechsler Abbreviated Scale of Intelligence (WASI) for measuring the cognitive ability. It consists of four subtests: Vocabulary, Block Design, Similarities and Matrix Reasoning. Scores of these subtests lead to calculate performance IQ (PIQ), verbal IQ (VIQ) as well as a full scale IQ (FSIQ). FSIQ will measure the cognitive ability.
次要结局
- School achievement(single time point at follow up after an average of 6 years of the original study)
- Number Stroop(single time point at follow up after an average of 6 years of the original study)
- Digit span(single time point at follow up after an average of 6 years of the original study)
- Children's MUAC(single time point at follow up after an average of 6 years of the original study)
- Children's OFC(single time point at follow up after an average of 6 years of the original study)
- Mother's weight(single time point at follow up after an average of 6 years of the original study)
- Mother's MUAC(single time point at follow up after an average of 6 years of the original study)
- Strength and difficulties questionnaire (SDQ)(single time point at follow up after an average of 6 years of the original study)
- Memory subtests of NEuroPSYchological (NEPSY) Assessment(single time point at follow up after an average of 6 years of the original study)
- Home Observation for Measurement of Environment (HOME)(single time point at follow up after an average of 6 years of the original study)
- Socio economic status (SES)(single time point at follow up after an average of 6 years of the original study)
- Children's Height(single time point at follow up after an average of 6 years of the original study)
- Fine motor skills(single time point at follow up after an average of 6 years of the original study)
- Children's Weight(single time point at follow up after an average of 6 years of the original study)
- Mother's height(single time point at follow up after an average of 6 years of the original study)
