Gravitas Feeding Tube System Placement in Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Percentage of accurate verifications of anatomical locations of the tip of the Gravitas feeding tube.
研究概览
简要总结
The purpose of this study is to optimize 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
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Weeks 至 18 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age at enrollment: 0 to 18 weeks post-partum. Can be up to 12 weeks preterm (gestational age ≥ 28 weeks).
- •Suitable to start enteral feeding
- •Anticipated to receive enteral feeding (either bolus or continuous feeds) for more than 6 hours and conclude the enteral nutrition while in the care of the NICU. If enteral nutrition has already been initiated, indicated for replacement of an orogastric/nasogastric feeding tube.
排除标准
- •Known major upper airway malformation (e.g. tracheoesophageal fistula)
- •Known major GI malformation (e.g. malrotation)
- •NPO status -neonate expected to remain NPO for the following 72 hours
- •Has a medical condition that drastically affects gastric acid-secretion (e.g. Zollinger-Ellison Syndrome, congenital achlorhydria, gastrointestinal perforation/leak/obstruction)
- •Has had removal of part of the stomach
- •Critically ill, facing imminent death
- •Neonate on ECMO
- •Deemed unsuitable for enrollment in study by the site principal investigator based on the patients' medical history
- •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.
结局指标
主要结局
Percentage of accurate verifications of anatomical locations of the tip of the Gravitas feeding tube.
时间窗: 5 months
Data collected during the study will be post processed to refine the Gravitas placement algorithm. The position of the feeding tube tip as processed by the Gravitas placement algorithm will be compared to institutional standard of care.
Percentage of accurate removals/dislodgements identified by the Gravitas dislodgement algorithm.
时间窗: 5 months
Data collected during the study will be post processed to refine the Gravitas placement algorithm. The removal/dislodgement of the feeding tube tip as processed by the Gravitas placement algorithm will be compared to actual removal/verification of dislodgement by institutional standard of care.
Adverse events (a) related to placement and (b) throughout the duration of the presence of the feeding tube within the patient.
时间窗: 5 months
The number and type of adverse events will be collected.
次要结局
未报告次要终点