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临床试验/NCT00875251
NCT00875251Unknown不适用

Growth and Body Composition of Very Low Birth Weight Infants Compared With Infants Birth at Term

Oswaldo Cruz Foundation2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
body composition

研究概览

简要总结

Growth is traditionally used as a prognostic measure after admission to a neonatal intensive care unit (NICU). Quality of neonatal intensive care is one of the factors determining the health and quality of life for those that survive, with the principal objective of increasing disability-free survival. Nowadays, there is some researches showing us that these preterm babies present a different body composition when they achieve term age compared with babies birth at term and this condition could be putting these babies in risk to metabolic syndrome early in adult age. The majority of infants born between 24 and 29 weeks of gestational age fail to achieve the mean birth weight for fetuses of the same gestational age, and many weigh below the 10th percentile at hospital discharge. The focus of this study is the growth and body composition of very low birth weight infants growing in the extrauterine environment. The central question is, when they reach the corresponding term weight, is the body composition of newborns growing outside of the uterus different from that of infants growing in the intrauterine environment? The investigators are also trying to validate 3 different methods to research body composition: DXA, air-displacement plethysmography and electric bioimpedance.

详细描述

OBJECTIVES

GENERAL:

Evaluate the growth and body composition of VLBW infants upon reaching the corresponding term gestational age (GA) and weight.

SPECIFIC:

A) Evaluate the longitudinal growth and body composition of VLBW infants from the first week of life and at the corresponding term GA and weight.

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
— 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • appropriate for gestational age (AGA) and small for gestational age (SGA) premature newborns with gestational age less than or equal to 32 weeks and less than 1500g at birth
  • AGA term newborns with gestational age greater than or equal to 37 weeks and less than 42 weeks and with no history of maternal disease that might compromise intrauterine growth

排除标准

  • congenital malformations
  • genetic syndromes confirmed by the geneticist
  • clinically and laboratory-confirmed congenital infections
  • children of mothers with the human immunodeficiency virus (HIV)
  • children of diabetic mothers
  • newborns that develop severe intraventricular hemorrhage or necrotizing enterocolitis

结局指标

主要结局

body composition

时间窗: from discharge to 3 months of chronological age

fat mass and fat free mass from PEA BOD

次要结局

  • anthropometry(from term to first year of life)

研究者

发起方
Oswaldo Cruz Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Elisabeth Lopes Moreira

MD, PhD

Oswaldo Cruz Foundation

研究点 (2)

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