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临床试验/NCT06909929
NCT06909929Enrolling By Invitation不适用

Pemberian Lipid Intravena Dosis Tinggi Untuk Bayi Sangat Prematur Atau Berat Lahir Sangat Rendah Terhadap Pertumbuhan

Indonesia University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年9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
Enrolling By Invitation
入组人数
70
试验地点
1
主要终点
return to birth weight

研究概览

简要总结

This is a RCT study conducted in Cipto Mangunkusumo Hospital in very preterm infants. The investigators compared early intravena lipid start with 2 gram per body weight and 1 gram per body weight and observed the time to reach birth weight.

详细描述

Neonates with <32 weeks gestation age or <1500 gram birth weight gets early intravena lipid start with 2 gram per body weight and 1 gram per body weigh then observed the time to reach birth weight

研究设计

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

入排标准

年龄范围
— 至 32 Weeks(Child)
性别
All
接受健康志愿者
否

入选标准

  • •birth weight below 1500 gram or gestational age below 32 weeks

排除标准

  • •mayor congenital abnormalities

研究组 & 干预措施

2 gram

Experimental

This group will get 2 g of lipid IV in the early 24 hours of life

干预措施: Lipid IV 2 g (Dietary Supplement)

1 gram

Active Comparator

This group will get 1 g of lipid IV in the early 24 hours of life

干预措施: lipid IV 1 gram (Dietary Supplement)

结局指标

主要结局

return to birth weight

时间窗: day

time of the participants to reach back the birth weight up to 28 days of age

次要结局

未报告次要终点

研究者

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

Putri Maharani Tristanita Marsubrin, MD, PhD

Principal Investigator

Indonesia University

研究点 (1)

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