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临床试验/NCT00769509
NCT00769509已完成4 期

Energy Expenditure Assessment of Preterm Infant With Very Low Birth Weight Fed With Human Milk or Preterm Formula

Oswaldo Cruz Foundation2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2009年3月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
25
试验地点
2
主要终点
Energy expenditure adjusted by caloric density of milk in both groups measured by open system indirect calorimetry pre and pos feed With humam milk or preterm formula

研究概览

简要总结

The goal of this study is verify if the energy expenditure in preterm infant fed with human milk is different from preterm formula. A randomized, controlled, crossover, double blind clinical trial will be carried out in which the newborn will be its own control. Randomization will be according to the type of diet at the beginning of the study. Half of the participants will be randomly assigned to begin the study using one type of milk (for example, human milk) and later another type of milk (preterm infant formula) and the other half will do the opposite.

详细描述

Post-natal growth restriction has become a problem yet to be solved and studied in most neonatal units. Newborns with very low birth weight grow at a rate lower than expected, thus culminating with delayed extra-uterine growth, be it in the term assessment, be it at the time of discharge from the hospital, and this makes the search for adequate nutrition a critical issue. Although there are intrinsic risk factors related to prematurity, the nutritional approach of the neonatal unit staff plays a decisive role on the prevalence of malnutrition.

Although the importance of appropriate nutritional management of premature infants has been clearly recognized, the necessary nutrient requirements of most nutrients have not been well established yet and these uncertainties may contribute to a limited intake of nutrients (Hay et al, 1999).

When fresh and extracted mother´s own milk, human milk has been considered the preferred feed for premature newborns, because of its digestibility, balanced chemical composition, capacity to provide immunity and prevention of future diseases (AAP, 2003). In addition, human milk has been associated to lower energy expenditure to be used in comparison with preterm formula, and this may promote the newborn's growth (Lubetzky et al, 2003). However, many of its advantages can be lost when human milk comes from a pool and is pasteurized, and its use has been associated to inadequate weight gain and a nutritional deficit during hospital stay. Thus it is sometimes necessary to use human milk with fortifier or preterm formula, to feed the preterm infant, in order to increase caloric-protein supply and weight gain. Milk formulas for premature babies have currently high caloric density and are better digested, but they do not have the capacity to provide immunity. In face of this problem, several studies are in progress to know and discuss the best nutritional approach for premature newborns during hospital stay. Among the factors that may have an impact on this approach is energy expenditure originated from the type of diet newborns have and on how its caloric constituents (macronutrients) are metabolized.

In face of the aforesaid, the following question remains: Will individually adjusting the caloric density of human and formula milk fed to newborns with very low birth weight actually have any impact on energy expenditure?

2 - OBJECTIVES

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
3 Weeks 至 5 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Premature infant admitted to the Intensive Care Unit of Fernandes Figueira Institute with birth weight under 1500g, adequate for their gestational age, clinically stable, without congenital malformations, nor genetic syndromes confirmed by the geneticist, nor congenital infections confirmed by the physician and lab tests will be eligible for this study, as well as newborn infants who developed intra-ventricular hemorrhage (grades III and IV).

排除标准

  • Premature infant that present the following in their exams shall be excluded: significant gastric residue, signs and symptoms of sepsis, repeated apnea events which required the use of respiratory stimulants.

研究组 & 干预措施

preterm formula

Experimental

Assessment of energy expenditure of preterm infant during fed with preterm formula

干预措施: energy expenditure in preterm fed with preterm formula (Other)

human milk with fortifier

Active Comparator

Assessment of energy expenditure by indirect calorimetry during fed with human milk with fortifier

干预措施: assessment of energy expenditure (Other)

结局指标

主要结局

Energy expenditure adjusted by caloric density of milk in both groups measured by open system indirect calorimetry pre and pos feed With humam milk or preterm formula

时间窗: from 21 to 28 days of life

次要结局

  • weight gain velocity(2 weeks before and after intervention)

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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