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临床试验/NCT00668694
NCT00668694已完成不适用

Effect of Psychosocial Stimulation on Development of Iron-deficient Anemic Infants: A Randomized Controlled Trial

International Centre for Diarrhoeal Disease Research, Bangladesh2 个研究点 分布在 1 个国家目标入组 434 人开始时间: 2007年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
434
试验地点
2
主要终点
Mental and motor development.

研究概览

简要总结

In developing countries, poor nutrition, high morbidity, poverty, poor parental education and stimulation in the home, all detrimentally affect children's development. These conditions frequently occur together increasing the risk of poor development. Iron deficiency anemia (IDA) affects large numbers of young children and is associated with poor child development. There is some question as to whether infants with IDA can catch up in mental development to non-IDA infants. We plan to examine the effect of psychosocial stimulation on IDA children's growth and development using a randomized controlled trial and compare them with non-anemic children. The study will be located in poor villages accessible to Dhaka. Villages will be randomized to either receive psychosocial stimulation or none. Children, aged 6-12 months, with IDA (hemoglobin (Hb) 80.0-109g/L, ferritin<12μg/L & Transferrin Recepter (TfR) >7) (n=212) or without anemia (Hb>109g/L, ferritin>12μg/L, C-reactive protein (CRP) <5 & TfR<7) (n=212) will be identified in those villages. Intervention will include weekly home visits for 9 months by a play leader, who will demonstrate play with home made toys and teach the mothers about child development. All IDA children will be given 30 mg ferrous-sulphate daily for 9 months. At the beginning and end of the study, the following measurements will be made: Bayley Scales of Infant Development (mental and motor indices), Wolke's behavior ratings, Hb, serum ferritin, CRP, Transferrin receptor, anthropometry, home stimulation, and mothers' knowledge and practices of child development. Stool microscopy, maternal-urinary iodine (as a proxy to assess children's iodine status), dietary history, child rearing practices (parenting) of mothers, perinatal history and socioeconomic conditions will be assessed at the beginning and children's language development at the end. Depending on availability of funds serum TSH will also be measured in children to exclude iodine deficiency. We will also measure mothers' nutritional and mental status to assess its relationship with children's development. The treatment effect will be examined by intention to treat analysis using multiple regression of the outcome variables controlling for initial measures and multilevel analysis will be conducted to control for differences at village level. The findings of this project will have implications both for international and national policies on early childhood development programs for IDA children.

详细描述

In developing countries, millions of young children have developmental deficits due to poor nutrition, lack of a stimulating environment, and poverty. In Bangladesh, where poor nutrition, poverty and poor parental education are highly prevalent, the implications are serious not only for the individuals' future but also for national development.

Iron deficiency and child development There is increasing evidence that iron deficiency anemia detrimentally affects children's development (Grantham-McGregor and Ani 2001). Many cross sectional studies have shown that iron deficiency is associated with poor psychomotor development and behavioral deficits in young children, and poor cognition and school achievement in school-aged children. Furthermore, longitudinal studies have observed that children who are anemic in the first 3 years of life continue to have poorer cognition, school achievement and psychosocial well being than children who were not anemic (Grantham-McGregor and Ani 2001). However, anemia is associated with many adverse social and economic family circumstances (Lozoff et al. 1991;de Andraca et al. 1990), which may adversely affect children's development.

Anemic children who were treated with iron, failed to catch up with non-anemic children in developmental levels in several studies (e.g. Walter et al. 1989;Lozoff et al. 1987;Lozoff et al. 1996). A few randomized, controlled trials of iron treatment have been conducted with anemic young children (Stoltzfus et al. 2001;Idjarinata and Pollitt 1993;Aukett et al. 1986;Friel et al, 2001). In two of the trials, anemic children under four (Stoltzfus et al. 2001) or two years (Idjarinata and Pollitt 1993) achieved better development from iron supplementation. One of these studies in Indonesia involved only 25 treated anemic children (Idjarinata and Pollitt 1993). The other study was in Zanzibar and included many children with malaria and some severely anemic children (Stoltzfus et al. 2001) and only children with Hb <80g/L showed significant benefits in motor development but improvement in language milestones occurred in children with all levels of Hb. Two other randomized trials failed to show clear benefits (Aukett et al. 1986;Friel et al, 2001). One of them (Aukett et al. 1986) used an insensitive screening test to measure developmental outcomes and the other (Friel et al, 2001) compared the effect of low and high iron formula on the development of low birth weight children and no benefit was found in the high iron group. The high iron children actually had more respiratory infections.

A recent meta-analysis of randomised trials (Sachdev et al, 2005) found that while there is evidence that older anemic children benefit from iron in cognition there is no convincing evidence from children under 27 months. However, three more recent randomized trials of iron supplementation were not included (Black et al, 2004; Lind et al, 2004, Freil et al 2003). One in Bangladesh (Black et al, 2004) 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. Both the Indonesian (Lind et al, 2004) and Canadian studies (Freil et al 2003) 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 (Lozoff et al 2000).

Stimulation and child development Iron deficient children show less activity, more apathy and are less likely to explore their environment than iron replete children and thus acquire skills only slowly (Grantham-McGregor and Ani 2001). One reason for the failure of some anemic children to catch up in mental development to non-anemic children following treatment may be that they have missed opportunities to explore their environment. Thus, they may require extra play experiences to catch up in development. In addition, many anemic children come from homes with low levels of stimulation and other psychosocial disadvantages (Grantham-McGregor and Ani 2001), which may exacerbate their poor level of development.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
6 Months 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • All children will be aged 6 to 24 months, living in the defined rural area and have parental consent to join the study

排除标准

  • The following children will be excluded:
  • those with multiple births
  • congenital abnormalities
  • Bayley scores <55
  • Hb<80 g/L or severe wasting (weight for height <-3 z score)
  • Children with severe wasting or Hb<80 g/L will be referred to the Thana Health Complex for treatment.

研究组 & 干预措施

1

No Intervention

Anemia without stimulation.

2

Experimental

Anemia with stimulation

干预措施: Stimulation (Behavioral)

3

No Intervention

Non-anemic group: Hb >80-109 g/L ferritin levels >12 μg/L and TfR <6 will be enrolled without stimulation

4

No Intervention

Non-anemic group: Hb >80-109 g/L ferritin levels >12 μg/L and TfR <6 will be enrolled with stimulation

结局指标

主要结局

Mental and motor development.

时间窗: 9 months

次要结局

  • Anthropometry(9 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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