跳至主要内容
临床试验/NCT04233333
NCT04233333Unknown不适用

Fixation of the Orogastric Tube: Which Method for the Newborn ?

Centre Hospitalier Universitaire de la Réunion1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年2月12日最近更新:
适应症
干预措施

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

Active Comparator

干预措施: method of fixation of the orogastric tube (Device)

W.K fixation

Experimental

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)

研究者

发起方
Centre Hospitalier Universitaire de la Réunion
申办方类型
Other
责任方
Sponsor

研究点 (1)

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