NCT07409038尚未招募不适用
Effect of Early Human Milk Fortification Versus Delayed Fortification on Growth and Feeding Tolerance in Premature Infants: a Randomized Controlled Trial.
Children's Hospital and Institute of Child Health, Multan1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2026年2月1日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- weight gain
研究概览
简要总结
The main purpose of the study is to evaluate the effect of early human milk fortification versus delayed fortification on growth and feeding tolerance in premature infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 28 Weeks 至 31 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants born at 28-31+6 weeks' gestation and/or birth weight1000-1500g.
- •Exclusively receiving mother's own milk or donor human milk.
- •No major congenital anomalies, severe sepsis, or NEC at enrollment.
- •Parental/guardian consent
排除标准
- •Extremely pre-term infants
- •Infants with congenital gastrointestinal malformations or metabolic disorders.
- •Infants with confirmed necrotizing enterocolitis(NEC)Stage II/III or intestinal perforation before enrollment (as these cases indicate significant gastrointestinal morbidity that may interfere with feeding tolerance and growth assessment).
- •Infants whose parents decline participation.
研究组 & 干预措施
delayed initiation of human milk fortification on feeding tolerance
Other
delayed initiation of human milk fortification on feeding tolerance
干预措施: early initiation of human milk fortification on feeding tolerance (Dietary Supplement)
结局指标
主要结局
weight gain
时间窗: 2 to 3 months
● ≥15-20 g/kg/day (or as per predefined growth standards for preterm infants).
● Linear growth & head circumference
时间窗: 2 to 3 months
* Increase in length ≥0.8-1.0 cm/week. * Head circumference growth ≥0.5-0.8 cm/week
次要结局
- ● Successful enteral feeding advancement(2 to 3 months)
- ● Absence of intolerance signs(2 to 3 months)
研究者
Dr. Muhammad Asif
postgraduate resident of peads medicine
Children's Hospital and Institute of Child Health, Multan
研究点 (1)
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