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临床试验/NCT02353013
NCT02353013已完成不适用

Effect of Protein Intake on Preterm Infant Body Composition

University of Oklahoma2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2014年12月最近更新:
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
36
试验地点
2
主要终点
Weight gain due to fat mass

研究概览

简要总结

The investigators will compare weight gain based on fat accretion and change in body composition in preterm infants receiving different amounts of enteral protein.

详细描述

American Academy of Pediatrics guidelines define the growth rate of preterm, underweight babies as adequate if it matches the age-equivalent weight gains typical of term infants, approximately 10-15 grams per kg per day. Unfortunately, many pre-terms, especially very low birth weight ones, do not achieve this rate, resulting in neurodevelopmental deficits and low discharge weights. Typical feeding regimens, designed to increase weight gain, however, have been shown to increase the rate of fat accretion and increase the risk of obesity and metabolic disorders, such as insulin resistance and type 2 diabetes, later in life. Research has shown that higher protein diets can reduce the accretion of body fat in older, normal weight infants but this has not been systematically tested in low birth weight pre-terms. The current study will compare weight gain based on fat accretion and change in body composition in preterm infants receiving higher (4g/100 kcal) versus lower (3 g/100 kcal) protein-energy ratio diets. The hypothesis tested in this study is: Increased protein intake will reduce the percentage of weight gain due to fat accretion in pre-term infants. The identification of an effective feeding regimen that would both allow pre-term infants to acquire age-equivalent growth rates similar to those of term infants while avoiding the excess accretion of body fat could significantly improve the long term health outcomes of this high-risk population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
1 Minute 至 1 Year(Child)
性别
All
接受健康志愿者

入选标准

  • Premature infants born less than 32 weeks EGA
  • Growth that is appropriate for gestational age (AGA)
  • Admitted to OU Children's NICU, inborn or outborn
  • Receiving enteral feedings <100 mL/kg/day
  • Hemodynamically stable

排除标准

  • Severe congenital anomalies to include congenital heart disease, chromosomal anomalies, open neural tube defects, and/or intestinal anomalies precluding enteral feedings
  • Growth restriction, growth that is small for gestational age (SGA) or large for gestational age (LGA)
  • Inborn errors of metabolism
  • History of necrotizing enterocolitis Bell stage III
  • Cerebrospinal fluid indwelling shunt (affects body composition measurements)
  • Expected death prior to 36 weeks EGA (the end of the study period)
  • Inability to meet Pea Pod® requirements for the first measurement
  • On vasopressor medications

研究组 & 干预措施

Standard Protein Group

Active Comparator

For infants in this group, the target protein-energy ratio (PER) will be ~3 g/100 kcal. This will be achieved by providing standard fortification by adding a commercially available human milk fortifier to human milk or by providing a preterm formula.

干预措施: Standard fortification (Dietary Supplement)

Enhanced Protein Group

Experimental

For infants in this group, the target protein-energy ratio (PER) will be ~4 g/100 kcal. This will be achieved by providing standard fortification by adding a commercially available human milk fortifier to human milk or by providing a preterm formula. In addition, liquid protein will be added to provide protein supplementation and increase the PER.

干预措施: Protein supplementation (Dietary Supplement)

Enhanced Protein Group

Experimental

For infants in this group, the target protein-energy ratio (PER) will be ~4 g/100 kcal. This will be achieved by providing standard fortification by adding a commercially available human milk fortifier to human milk or by providing a preterm formula. In addition, liquid protein will be added to provide protein supplementation and increase the PER.

干预措施: Standard fortification (Dietary Supplement)

结局指标

主要结局

Weight gain due to fat mass

时间窗: 4 weeks

次要结局

  • Change in body weight(4 weeks)
  • Change in percent fat mass(4 weeks)
  • Change in length(4 weeks)
  • Change in head circumference(4 weeks)

研究者

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

Courtney B. Atchley, DO

Assistant Professor of Pediatrics

University of Oklahoma

研究点 (2)

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