NCT07088302招募中不适用
Effect OF Lactase Enzyme Supplements ON Protection Against Feeding Intolerance IN Preterm Neonates
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Feeding intolerance:
研究概览
简要总结
This study aims to study the effect of lactase enzyme in preventing feeding intolerance in preterm neonates in neonatal intensive care unit at Alexandria University Children's Hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Days 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •will be as follows:
- •Preterm neonates ≤ 32 weeks gestational age.
- •Start feeding in the first 72 hours of life. 8.
排除标准
- •Patients with any of the following will be excluded:
- •Parental consent lacking/refusal.
- •Obvious major congenital abnormalities.
- •Infants more than 72 hours of age at the time of randomization.
- •Delayed introduction of feeding (beyond three days of life).
- •Known galactosemia.
- •Severe IUGR. -
研究组 & 干预措施
Lactase enzyme group
Active Comparator
干预措施: lactase administration (Drug)
Control group
Placebo Comparator
干预措施: placebo (Other)
结局指标
主要结局
Feeding intolerance:
时间窗: first two weeks of life
vomiting number per day aspirates in ml/day abdominal distension by measuring abdominal circumference before and after feeds
次要结局
未报告次要终点
研究者
Marwa Mohamed Farag
Assistant professor of Pediatrics
Alexandria University
研究点 (1)
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