Early Versus Late Enteral Iron Supplementation in Infants With a Birth Weight of Less Than 1301g - Neurocognitive Development at 5.3 Years Corrected Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- the number of infants who fulfilled the criteria of ID at any time throughout the study.
研究概览
简要总结
Background: Iron deficiency in early childhood may impair neurodevelopment.
Aim: To examine whether early iron supplementation improved neurodevelopment in preterm infants.
Method: Children who participated in a clinical trial of iron supplementation were invited for a neurodevelopmental follow-up examination at the time of school entry.
详细描述
Children with a birth weight of < 1301g who participated in a randomized controlled trial of early versus late enteral iron supplementation were evaluated applying a standardized neurological evaluation, the Kaufmann Assessment Battery for Children, and the Gross Motor Function Classification Scale (GMFCS) at the age of school entry.
Severe disability was defined as any of the following: any abnormal neurological examination associated with a severely impaired mobility (GMFCS>1), severe cognitive impairment (mental processing composite (MPC) <51), hearing loss requiring amplification, or blindness. The absence of disability was defined as normal neurological examination, normal mobility (GMFCS=0), and normal cognitive development (MPC>85) and the absence of any severe hearing and visual impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single
入排标准
- 年龄范围
- 4 Years 至 7 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •inborn infants with a birth weight of <1301g admitted between June 1996 and June 1999
排除标准
- •major anomalies, hemolytic disease, twin-to-twin transfusion syndrome, missing parental consent
结局指标
主要结局
the number of infants who fulfilled the criteria of ID at any time throughout the study.
ferritin at 61 days of life
次要结局
- Disability Status
- Behavioural Problems
- Neurological Status
- Mental Processing Composite (Kaufmann Assessment Battery for Children)
