Fixation of the Orogastric Tube: Which Method for the Newborn ?
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Average duration of holding the fixation
研究概览
简要总结
It is recommended to respect the perioral zone by fixing the feeding tube only on the newborn's cheek, in order to promote oral acquisition and avoid repeated dislodgment of probes (HAS). This rule is easily applicable for nasogastric tubes. The difficulty is found for orogastric tubes. The "mustache" is usually used to fix it, but this interferes with the perioral zone and must be changed more often than necessary.
To achieve a more sustainable orogastric tube's fixation to the cheek, a German team directed by W. Krämer developed and tested an orogastric tube's fixing technique that was subsequently approved and used.
Using this German method, a randomized, monocentric superiority study, including 30 newborns and premature babies requiring an orogastric tube, will compared german probe's fixation method to the mustache.
The aim of the study is to ensure a more effective orogastric tube's fixation to reduce the number of fixation changes, probe placements and negative oral stimulations in newborns.
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
- None
入排标准
- 年龄范围
- — 至 2 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns admitted to neonatal intensive care unit
- •Express consent of the holders of parental authority
- •Orogastric tube indication (enteral feeding, digestive aspiration)
排除标准
- •Newborns over 2 months of age corrected
- •Indication of nasogastric tube
- •Port of gastrostomy
- •Pathology resulting in hypersalivation or hyper sweating
- •Swallowing disorder
- •Genetic disease
- •Severe neurological impairment
- •Cleft lip and / or palate
- •Other malformation in the oral sphere or perioral area
- •Sedation with morphine analgesics
- •Anticonvulsant treatment
- •Palliative care
研究组 & 干预措施
mustache fixation
干预措施: method of fixation of the orogastric tube (Device)
W.K fixation
干预措施: method of fixation of the orogastric tube (Device)
结局指标
主要结局
Average duration of holding the fixation
时间窗: 7 days
次要结局
- Number of tube's dislodgements(7 days)
