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临床试验/NCT01609868
NCT01609868已完成不适用

The Effect of a Liquid Protein Modular on Growth and Outcomes in the NICU

University of Nebraska1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年6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
Growth in premature infants (percentile ranking at 36 weeks CGA)

研究概览

简要总结

The investigators hypothesis that premature infants receiving a commercially available liquid protein modular will have improved growth when compared with premature infants receiving a commercially available powder protein modular.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
— 至 40 Weeks(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Infants less than 2000 gms at birth, receiving maternal breast milk

排除标准

  • •Infants receiving formula

研究组 & 干预措施

control

Active Comparator

infants in this arm will receive the current treatment that is standard of care for these infants, powder protein modular to achieve 4 gm/kg/day

干预措施: Powder protein modular (Dietary Supplement)

experimental

Experimental

this group will receive a liquid protein modular that recently became commercially avaliable, to achieve the same protein of 4 grm/kg/day as the powder comparision group

干预措施: Liquid protein modular (Dietary Supplement)

结局指标

主要结局

Growth in premature infants (percentile ranking at 36 weeks CGA)

时间窗: birth to 36 weeks

次要结局

  • GI tolerance(birth to 36 weeks)

研究者

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

Corrine K. Hanson, PhD

IRB Administrator

University of Nebraska

研究点 (1)

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