NCT05744193终止不适用
Comparison of Multinutrient Human Milk Fortifiers in Preterm Infants: A Non-inferiority Single-blind, Randomized Controlled Trial (RCT)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 6
- 主要终点
- Weight gain
研究概览
简要总结
A multi-center, single-blind, randomized, controlled, parallel-designed, prospective trial to compare growth between preterm infants fed one of three study human milk fortifiers added to human milk
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 168 Days 至 224 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically and metabolically stable
- •Birth weight 700 g to less than or equal to 1,250 g
- •Appropriate birth weight for gestational age
- •24 0/7 to 32 0/7 weeks' gestational age at birth
- •Exclusively fed human milk
- •Signed informed consent and authorization to use and/or disclose PHI
排除标准
- •Metabolic or chronic disease
- •5-minute Apgar score <4
- •Major surgery
- •Ventilator dependent
- •Fluid restriction
- •Grade III or IV intraventricular hemorrhage (IVH)
研究组 & 干预措施
Commercial Liquid Human Milk Fortifier
Active Comparator
Liquid human milk fortifier to be added to human milk
干预措施: Exempt Infant Formula (Other)
Liquid Human Milk Fortifier - Standard Protein
Experimental
Liquid human milk fortifier to be added to human milk
干预措施: Exempt Infant Formula (Other)
Liquid Human Milk Fortifier - High Protein
Experimental
Liquid human milk fortifier to be added to human milk
干预措施: Exempt Infant Formula (Other)
结局指标
主要结局
Weight gain
时间窗: Daily for 28 days
grams/kg/day
次要结局
- Total protein intake(28 days)
- Feeding Tolerance(Daily for 28 days)
- Metabolic Acidosis(Study days 0, 14, 28)
- Rate of Length and head circumference gain(weekly up to day 28)
- Total energy intake(28 days)
- Respiratory status(28 days)
- Incidence of sepsis - culture for pathogens(Study day 0 through 28)
- Incidence of sepsis - Antibiotic use(Study Day 0 through 28)
- Incidence of NEC(Study Day 0 through 28)
- Incidence of sepsis - clinical symptoms(Study Day 0 through 28)
- Total serum CO2(Study days 0, 14, 28)
研究者
研究点 (6)
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