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临床试验/NCT04143204
NCT04143204已完成不适用

Early Nutritional Intake and Growth in Very Preterm or Very Low Birth Weight Infants: a Prospective Cohort Study

Children's Hospital of Fudan University1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
180
试验地点
1
主要终点
Z-scores of weight

研究概览

简要总结

This study aims to explore the relation of early nutritional intake, especially oral nutrition intake, with growth and body composition among very preterm or very low birth weight infants.

详细描述

As the survival of very preterm infants increases, it is important to evaluate their long-term outcomes. Nutritional intake during early life was important to the growth and development in infants, especially in preterm infants. Studies found that early nutrition exposure in preterm infants can effect scored of Griffith Mental Development Scales and body fat percentage at later life. Insulin-like growth factor-1, leptin, Ghrelin, C-Peptide are associated with fat mass in children. And accumulation of fat and insulin resistance (IR) in the early postnatal period are related to metabolism diseases in adulthood. However, previous studies on nutrition and growth or the body composition of preterm infants were mostly completed in developed countries, and no relevant data were available in China. Therefore, this study aims to establish a prospective cohort of very preterm infants to observe the effects of nutritional exposure in early life on growth and body composition in later life.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Day 至 18 Months(Child)
性别
All
接受健康志愿者

入选标准

  • infants born with a gestational age >=28 weeks and <32 weeks and/or a birth weight >=1000g and <1500g;
  • infants admitted to neonatal intensive care unit (NICU) of Children's hospital of Fudan University within 24h after birth.

排除标准

  • major congenital anomalies or heredity metabolic diseases;
  • severe disease or abdominal surgery during hospitalization;
  • death during hospitalization or discharge without medical advice;
  • small for gestational age.

结局指标

主要结局

Z-scores of weight

时间窗: at corrected age 40 gestational weeks

Computed according to the Fenton preterm growth standards (2013)

次要结局

  • Z-scores of length/height(at corrected age 6 months and 18 months)
  • Cognitive development outcome(at corrected age 18 months)
  • Body fat free mass(at corrected age 40 gestational weeks and 6 months)
  • Z-scores of weight(at corrected age 6 months and 18 months)
  • Body fat mass(at corrected age 40 gestational weeks and 6 months)
  • Intestinal flora change(from birth to corrected age 18 months)
  • Z-scores of head circumference(at corrected age 6 months and 18 months)
  • Percentage of infants who achieve catch-up growth(at corrected age 6 months and 18 months)
  • Body fat proportion(at corrected age 40 gestational weeks and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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