NCT05914064进行中（未招募）不适用
Gravitas Feeding Tube System Placement Validation in Neonates
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Incidence of device and procedure-related adverse events that occur while the feeding tube is within a subject. The number and type of adverse events will be collected.
研究概览
简要总结
The purpose of this study is to validate the Gravitas Feeding Tube System Placement Algorithm for NICU patients and to evaluate the safety and effectiveness of the Gravitas Feeding Tube in the neonate population for the administration of nutrition, fluids and medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 0 Weeks 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants in the Newborn Intensive Care Unit or on the general medical floor requiring a 5-8 Fr NG tube. The desired size of the feeding tube should be determined clinically, and the Gravitas 5-8 Fr Feeding Tube should only be placed if that size is appropriate.
- •Age at enrollment: 0 to 2 years post-partum. Can be up to 15 weeks preterm (gestational age ≥ 25 weeks).
- •Suitable to start or continue gastric enteral feeding, or otherwise clinically indicated to receive a feeding tube.
- •If enteral nutrition has already been initiated, the orogastric/nasogastric feeding tube may be replaced with a Gravitas Feeding Tube.
- •Ability to have a legally authorized representative provide informed consent Both neonates on a ventilator (non-invasive or invasive ventilation) or not requiring a ventilator are eligible for this study.
排除标准
- •Known major upper airway malformation (e.g. tracheoesophageal fistula)
- •Known major GI malformation (e.g. malrotation, esophageal atresia, etc.)
- •History of gastrectomy or esophagectomy
- •Expected survival of less than one week
- •Neonate on ECMO
- •Deemed unsuitable for enrollment in study based on the judgement of the site principal investigator for any other reason
- •Requirement for post-pyloric feeds (distal to stomach)
- •Infant has a basilar skull fracture
结局指标
主要结局
Incidence of device and procedure-related adverse events that occur while the feeding tube is within a subject. The number and type of adverse events will be collected.
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (10)
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