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临床试验/NCT00134771
NCT00134771已完成不适用

Trial of Nutritional Supplementation in Infants Born Small for Gestational Age

Institute of Child Health12 个研究点 分布在 1 个国家开始时间: 2001年2月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
试验地点
12
主要终点
Weight, length, head circumference at 6 months

研究概览

简要总结

The purpose of this study was to determine whether giving a nutrient enriched formula to infants born small-for-gestational age benefits blood pressure, growth and body composition by six months of age.

详细描述

Infants born small for gestational age often show impaired growth during childhood and reduced height as adults. Infants who are breast-fed from birth show greater 'catch-up' growth during the first few months of life than those who are formula fed but it is not clear what factors in breast milk (ie protein, nucleotides, LCPUFAs) are responsible for this 'catch-up' growth. This RCT compares the effects of using an enriched formula with increased protein and modified triglyceride (palmitate predominantly in Sn-2 position) against a standard infant formula from birth to six months on infants whose birth weights are below the 20th centiles for gestational age.

Infants are measured by a research midwife within 10 days of birth (at randomisation), 8, 16 and 26 weeks of age. At randomisation consent from the mother is taken and information collected about the pregnancy, social, demographic and medical data. At this and each further visit anthropometric measurements including skinfolds will be collected in addition to blood pressure and bio-electrical impedence at six months. A sub-sample of infants will have their body composition assessed by deuterium labelled water at six months. Data on health, weaning diets and bowel function are also collected at each visit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Ect
盲法
Double

入排标准

年龄范围
0 Years 至 10 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Infants who are formula fed from birth
  • Infants whose birthweights are less than 20th centile
  • Singleton births
  • Gestation > 37 weeks
  • Infants free from major congenital disease

排除标准

  • Infants who are breast-fed
  • Multiple births
  • Birthweight > 20th centile
  • Infants with congenital disease
  • Gestation < 37 weeks

结局指标

主要结局

Weight, length, head circumference at 6 months

次要结局

  • Blood pressure at six months
  • Body composition at 6 months

研究者

申办方类型
Other

研究点 (12)

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