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临床试验/NCT02605577
NCT02605577Unknown不适用

Research of Systemic Management for Late Preterm Infants Nutrition in China

Peking Union Medical College Hospital0 个研究点目标入组 2,000 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,000
主要终点
circumference gain(cm/week)

研究概览

简要总结

The purpose of the project is to investigate the status of nutrition management of late preterm infants in the member hospitals in the Beijing association of preterm infants, and set up the systemic nutritional management of late preterm infants, Including parenteral nutrition and enteral feeding. And to compare the differences of growth and complications of these infants between groupings applicationg and not applicating the systemic nutritional management of late preterm infants,and to validate its feasibility and validity.

详细描述

The research content of the project includes three parts:

  1. Investigation on nutritional status of late preterm infants.
  2. Setting up systemic nutritional management of late preterm infants
  3. Comparing nutritional and growth status of the late preterm, short-term and long-term complications between the groups applicating and not applicating the systemic nutritional management of late pretern infants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • preterm infants with gestational age 34 weeks to 36 weeks and 6 days

排除标准

  • preterm infants with gestational age<34 weeks or >36 weeks and 6 days
  • abnormality of digestive system
  • genetic and metablic disease
  • severe congenital heart disease( with hemodynamic changes that influencing enteral feeding)

结局指标

主要结局

circumference gain(cm/week)

时间窗: 29 months

days of postnatal life when enteral nutrition reaching 120kcal/kg/d

时间窗: 29 months

length gain(cm/week)

时间窗: 29 months

weight gain(g/kg/week)

时间窗: 29 months

次要结局

  • days of postnatal life when reaching full enteral nutrion(d)(29 months)
  • days of postnatal life with the lowst weight during hospitalisation(d)(29 months)
  • the lowest weight during hospitalisation(g)(29 months)
  • incidence of neonatal anemia(%)(29 months)
  • incidence of neonatal infection(%)(29 months)
  • incidence of hypebilirubinemia(%)(29 months)
  • proportion of breast milk feeding(%)(29 months)
  • days of postnatal life that regain birth weight(d)(29 months)
  • incidence of hypoglycemia(%)(29 months)
  • incidence of hyperglycemia(%)(29 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Li zhenghong

associate professor

Peking Union Medical College Hospital

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