NCT04561700撤回不适用
Nutritive Sucking Patterns in Premature Infants: A Randomized Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Time to independent oral feeding
研究概览
简要总结
In this pilot trial, the investigators will determine the feasibility of monitoring nutritive sucking patterns to facilitate the transition from tube to oral feeding in extremely-low-birth weight (ELBW) infants
详细描述
In this parallel-group randomized controlled trial, ELBW infants (birthweight < 1000 grams) will be randomly assigned in a 1:1 ratio to either weekly reporting on objective measurements of sucking activity during oral feeding (intervention group) or usual care without information on sucking activity (control group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Days 至 60 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birthweight < 1000 grams
- •Gestational age < 32 weeks of gestation
- •Full enteral feeding established before or on postnatal day 21
- •Oral feeding initiated before or at 33 weeks of postmenstrual age
排除标准
- •Major congenital/chromosomal anomalies
- •Patent ductus arteriosus causing significant cardiovascular symptoms
- •History of necrotizing enterocolitis stage 2 or greater
结局指标
主要结局
Time to independent oral feeding
时间窗: Birth to 120 days
Time interval in days from introduction of oral feeding to full independent oral feeding
次要结局
- Length of hospital stay(Birth to 120 days)
- Postnatal age at discharge(Birth to 120 days)
- Growth rate during the transition from tube to oral feeding(Birth to 120 days)
- Tube feeding events per day during the transition from tube to oral feeding.(Birth to 120 days)
研究者
Ariel A. Salas
Assistant Professor
University of Alabama at Birmingham
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