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临床试验/NCT01947972
NCT01947972已完成不适用

Individualized Maternal Milk Fortification for Feeding the Preterm Infants

Aristotle University Of Thessaloniki1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Mean protein intake per kg of body weight between the groups

研究概览

简要总结

Neonatal nutrition has to face a contradictory and conflicting nutritional regimen like a high percentage of amino acids from the first day of life in order to achieve normal neurodevelopment versus metabolic complications (insulin resistance, hyperglycemia, increased visceral fat) that this type feeding, in conjunction with complexity of prematurity, is likely to cause. Current study aims to investigate is whether individualized fortification of breast milk protein, based on the mother's milk protein content and targeting the recommended daily protein requirements, is associated with better nutrition, growth, biochemical and endocrine markers associated with the nutrition of preterm low birth weight neonates, compared to the standard fortification of human milk.

详细描述

Proteins are of the most important macromolecules in living organisms participating in almost all biological processes. Premature infants are forced to adapt to a new (extrauterine) environment where supply of nutrients, including amino acids, from mother ceases abruptly. Consequently, the aim of neonatologist is the appropriate, quantitatively and qualitatively nutritional support, to promote brain development, achieve normal endocrine and metabolic function, maintain a growth rate similar to the intrauterine one avoiding extrauterine growth restriction during postnatal period and at the same time encouraging the analogue modulation of body composition (increased muscle mass, decrease body fat, hydration).

Malnutrition or inadequate nutrition of preterm infant which remains undiagnosed and without proper treatment could have serious consequences on psychomotor development and metabolic activity. Indeed, 75% of low birth weight premature infants exhibit extrauterine growth restriction at discharge, even when they have achieved growth equal to the considered satisfactory, ie 15g/kg/day.

Beyond anthropometrics differences between preterm and full-term newborns, body composition varies as well. Preterms have higher percentage of body fat and decreased muscle mass at term time compared with full term neonates. However, it has not been clarified whether this differentiation is harmful predisposing to chronic diseases later in childhood or adult life (eg. obesity, metabolic syndrome).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
24 Hours 至 5 Days(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Infants with gestational age ≤ 34weeks
  • •very low birth weight (≤ 1500g)

排除标准

  • •maternal health problems contradicting breastfeeding
  • •genetic or chromosomal abnormalities
  • •metabolic contraindications for increased amount of protein

研究组 & 干预措施

protein intake of 4g/kg/d

Other

Tailored protein fortification and nutritional status of preterm neonate. 4.5g protein per kg for preterms with body weight less than 1000g and 4g protein per kg for preterms with body weight more than 1000g, after human milk analysis. Intervention regards protein supplementation to fulfil the exact protein needs of preterms

干预措施: Tailored protein fortification (Dietary Supplement)

结局指标

主要结局

Mean protein intake per kg of body weight between the groups

时间窗: participants will be followed until discharge and at 40 weeks post gestational age

次要结局

  • growth assessment differences between groups(participants will be followed until discharge and at 40 weeks post gestational age)
  • Differences in bioelectrical impedance between groups(participants will be followed until discharge and at 40 weeks post gestational age)
  • Mean daily dietary intake of mothers and correlation with macronutrients of their's breast milk(from the moment of intervention, at least once in 10days, and until the end of intervention)
  • Biochemical (lipidemic profile differences) between groups(at 36weeks post conceptual age and follow-up at 40 weeks postconceptual age)

研究者

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

Elisavet Parlapani

Dietitian - phD candidate

Aristotle University Of Thessaloniki

研究点 (1)

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