NCT00859092已完成2 期
Promotion of Thickened Feeds to Manage Newborns With Feeding Difficulties
David Oelberg, M.D.2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2008年3月最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Elimination of symptoms associated with immature swallowing
研究概览
简要总结
Swallowing dysfunction and delay of oral feeding skills in premature infants significantly delay discharge from the hospital. Thickening oral formula or breast milk feeds with commercial thickeners and rice cereal has been used in some nurseries with the goal of promoting development of adequate feeding skills. The objective of this pilot study is to examine the effect of thickened feeds on premature infants with oral feeding difficulties due to dysfunction secondary to immature swallowing.
Hypotheses:
- Thickened feeds will lead to a reduction in symptoms secondary to immature swallowing in 32-40 weeks gestational age infants when compared to non-thickened feeds
- Thickened feeds will promote transition to hospital discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •apneas and bradycardias with oral feedings
- •oxygen desaturations with oral feedings
- •excessive coughing or gagging with oral feedings
排除标准
- •less than 32 weeks adjusted gestational age
- •greater than 40 weeks adjusted gestational age
结局指标
主要结局
Elimination of symptoms associated with immature swallowing
时间窗: 2 days
次要结局
- Promotes transition to discharge from hospital(one week)
研究者
David Oelberg, M.D.
Principal Investigator
Eastern Virginia Medical School
研究点 (2)
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