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临床试验/NCT03662503
NCT03662503Unknown不适用

Initial Nutritional Strategy and Stature-level Growth During the Neonatal Period of Children Born Moderately Premature: Cohort EPIPAGE 2

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2018年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,000
试验地点
1
主要终点
head circumference

研究概览

简要总结

The growth and nutrition of premature infants during the neonatal period is a concern of neonatology services; it impacts the child's health in the short and long term. The weight deficit, but especially the weak growth of the cranial perimeter during the Neonatal period is associated with an increased risk of long-term neuro-cognitive impairment.

The optimal nutritional strategy, during the neonatal period, of children born moderately premature is not known.

The optimization of nutrition in premature children is therefore a topical issue in neonatology.

Our project aims to evaluate the impact of an aggressive early nutritional strategy characterized by optimized caloric and protein intakes on the stature-level growth of 2000 children born moderately premature GA from 30 WA (week of amenorrhea) to 32 WA + 6 days and included in the national cohort of follow-up of children of small gestational ages.

Nutritional intake during the first week of life will be analyzed in tertile. Children will be grouped according to their calorie and protein during the first week of life. The tertile 1 will represent the group of children with the lowest nutritional intake (called the "nutrition not aggressive "), the tertile 3 will define the group of children presenting the contributions highest nutritional levels (called the "aggressive nutrition" group).

The primary endpoint will be the z-score change in weight, height and head circumference between birth and age (36 adjusted age WA) between the "nonaggressive nutrition" group and the group. "Aggressive nutrition".

The benefits are for public health to harmonize neonatal care practices within a region and to better understand the impact of nutritional strategies on long-term neuro-cognitive development.

详细描述

The growth and nutrition of premature infants during the neonatal period is a concern of neonatology services; it impacts the child's health in the short and long term. The weight deficit, but especially the weak growth of the cranial perimeter during the Neonatal period is associated with an increased risk of long-term neuro-cognitive impairment.

The optimal nutritional strategy, during the neonatal period, of children born moderately premature is not known.

The optimization of nutrition in premature children is therefore a topical issue in neonatology.

Our project aims to evaluate the impact of an aggressive early nutritional strategy characterized by optimized caloric and protein intakes on the stature-level growth of 2000 children born moderately premature GA from 30 WA to 32 WA + 6 days and included in the national cohort of follow-up of children of small gestational ages.

Nutritional intake (calorie intake and total protein intake) during the first week of life will be analyzed in tertile.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Children born prematurely between 30 WA (week of amenorrhea) and 32 WA + 6 days
  • Included in the cohort EPIPAGE 2 with more than 4500 inclusions. The data Perinatal, neonatal and neuro-cognitive outcome at 2 years are available.
  • This will include 2,000 children meeting these criteria.

排除标准

  • Children with chromosomal abnormalities or malformations congenital
  • Children who died during the neonatal period

结局指标

主要结局

head circumference

时间窗: 36 weeks

head circumference in centimeters will be evaluate between birth and age (36 adjusted age SA)

weight

时间窗: 36 weeks

weight in kilograms will be evaluate between birth and age (36 adjusted age SA)

height

时间窗: 36 weeks

height in centimeters will be evaluate between birth and age (36 adjusted age SA)

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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