NCT06514014招募中不适用
Transition From Donor Milk: a Feasibility Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Fat free mass
研究概览
简要总结
Preterm and very low birth weight (VLBW, < 1,500g) infants who receive donor human milk (DHM) often experience slow postnatal growth and no clinical data is available to guide the duration of DHM for preterm infants. The investigators hypothesize that transitioning from DHM to preterm infant formula after the first month of life is both safe and conveys improved weight and length gains and fat free mass accumulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 28 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than 1,250 grams
- •At least 28 days of life
- •Diet consisting of donor human milk with/without mother's own milk
排除标准
- •Birth weight below the 5th percentile
- •History of necrotizing enterocolitis, spontaneous intestinal perforation, or other gastrointestinal disorder
- •Congenital anomalies
- •Care team discretion
研究组 & 干预措施
Donor Milk
No Intervention
Preterm Infant Formula
Active Comparator
干预措施: Preterm Infant Formula (Dietary Supplement)
结局指标
主要结局
Fat free mass
时间窗: 36 weeks post menstrual age
Fat free mass at 36 weeks post menstrual age
Weight Velocity
时间窗: 36 weeks post menstrual age
Weight velocity between birth and 36 weeks post menstrual age
次要结局
- Number of Patients with Bronchopulmonary dysplasia(36 weeks post menstrual age)
- Number of Patients with Retinopathy of prematurity(36 weeks post menstrual age)
- Number of Patients with Sepsis(36 weeks post menstrual age)
- Number of Patients with Necrotizing enterocolitis(36 weeks post menstrual age)
研究者
Brian Stansfield
Professor and Vice Chair for Research
Augusta University
研究点 (1)
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