NCT01799629终止不适用
Efficacy of Prophylactic Glycerin Suppositories for Feeding Intolerance in Very Low Birth Weight Preterm Infants: a Randomized Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 220
- 试验地点
- 3
- 主要终点
- days to achieve full tolerated feeding (breast milk or formula) by NGT or by mouth (140cc/kg/day)
研究概览
简要总结
To evaluate the efficacy of prophylactic glycerin suppositories will accelerate the elimination of meconium from the large intestine and thus reduce the incidence of feeding intolerance in very low birth weight (VLBW) infants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm infants with birth weight < 1250g.
- •Inborn or outborn infants
- •Less than 72 hours of age.
排除标准
- •Congenital malformations.
- •Acute abdomen needing surgical intervention.
- •Severity of illness such that death is likely in the first few days after birth.
- •Inability to get the parental consent.
研究组 & 干预措施
Intervention
Experimental
Intervention group will receive the glycerin suppository
干预措施: Glycerin suppositories (Drug)
结局指标
主要结局
days to achieve full tolerated feeding (breast milk or formula) by NGT or by mouth (140cc/kg/day)
时间窗: 2years
次要结局
- Incidence of feeding intolerance(2years)
- Incidence of necrotizing enterocolitis (NEC)(2years)
研究者
Emad Mohammad Khadawardi
Consultant Neonatology
King Faisal Specialist Hospital & Research Center
研究点 (3)
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