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临床试验/NCT02184650
NCT02184650已完成不适用

Early Nutrition and Neurological Development of Very Preterm Infants

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2014年7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
206
试验地点
1
主要终点
Neurological development

研究概览

简要总结

The main goal of this study is to determine, in preterm infants born with a GA < 32 weeks, the association between:

  • the quantity of mother's milk and duration and breastfeeding
  • the intake of polyunsaturated fatty acids and iron during hospitalizations

详细描述

The main hypothesis of this study is that the intake of lipid during hospitalization in neonatology department is associated with neurological development of preterm infants born with a GA < 32 weeks. The other hypotheses are that iron intake and the duration of breastfeeding are also associated with the development of preterm infants.

In the previous study EPINUTRI (NCT01486173), the development of infants was evaluated until the age of 1 year. EPINUTRI_3 is the follow-up of EPINUTRI until the age of 3 years.

The aim of EPINUTRI_3 study is to determine the association between lipid intake during hospitalization in neonatology department of preterm infants born with a GA < 32 weeks.

The secondary objective is :

- to evaluate the association between these factors and communication, developmental and social-emotional delays with the test " Ages and Stages questionnaire " (ASQ) at 3 years of age.

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
3 Years 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Premature infants previously included in EPINUTRI study
  • Non opposition of the parents for the collection of clinical and nutritional data

排除标准

  • Refusal of the parents to collect clinical and nutritional data

结局指标

主要结局

Neurological development

时间窗: At 3 years of age

Age and Stages Questionnaire

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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