jRCT2031210384已完成不适用
A Randomized, Controlled Study to Assess Growth and Safety of the Exclusive Human Milk Diet (EHMD) in Very Low Birth Weight (VLBW) Infants (<1,500 g)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 主要终点
- velocity of weight gain
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 0age 0month over 至 0age 0month under（—）
- 性别
- All
入选标准
- •1.VLBW infants (<1,500 g) born before 31 weeks 0 days gestational age
- •2.Within the first 10 days of life (day 0-10)
- •3.Diet consisted of 100% exclusive HM (MOM or DM) or NPO prior to study enrollment
- •4.Willing to follow the study diet and adhere to study procedures per the legal guardian
- •5.Written informed consent from the legal guardian of the infant
- •6.Informed consent obtained prior to reaching 50 ml/kg/day because this is when fortification begins
排除标准
- •1.Lethal or otherwise significant congenital abnormalities known at the time of inclusion 2.Chromosomal anomalies known at the time of inclusion 3.Known gastrointestinal malformation at the time of inclusion 4.Participation in another intervention trial aiming at having an effect on growth, nutrition, feeding intolerance, or severe complications such as NEC and sepsis in VLBW infants,
- •however it is permissible to participate in the interventional clinical trial of DM that is currently being run in Japan in parallel with this trial. 5.The subject is unable to start enteral feeding within the first 3 days of life and parenteral feeding within the first 2 days of life 6.Infants who, for medical reasons, cannot receive a feeding volume of at least 130 ml/kg/day 7.In the opinion of the investigator, the subject is incapable of receiving IMP and standard nutritional management. This may be due to very intensive respiratory support, medication needed to assist blood pressure, or need for multiple episodes of cardiopulmonary resuscitation on Days 1-2 of life, among others.
- •Those who have a history of hypersensitivity to the components of this drug.
- •Infant who develops NEC or sepsis prior to randomization must be excluded from the study.
结局指标
主要结局
velocity of weight gain
时间窗: from birth to 34 weeks and 0 days of gestation
The rate of growth [velocity of weight gain (g/kg/day)] (calculated by Patel's exponential method) during the period from birth to 34 weeks and 0 days of gestation will be evaluated to determine whether the rate of growth of subjects in the EHMD group is inferior to that of subjects in the standard nutrition group, with a non-inferiority margin of -1.45 g/kg/day.
次要结局
未报告次要终点
研究者
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