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临床试验/NCT06634329
NCT06634329尚未招募不适用

Assessment of the Comfort of Preterm Newborns During Feeding, Comparison of Different Methods of Milk Administration With Gastric Tube

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年11月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Comparing the tolerance of these different types of food (gravity versus pushing the seringue), based on the child's behavioral and physiological signs of well-being.

研究概览

简要总结

Preterm infants need aims of a tube named oral or naso gastric to grow until they acquire autonomy in suction-swallowing.

In fact, several modes feed by a gastric tube exist : using an electric syringe pump (continuous administration), or manual and individualization administration. In this second case, milk can be delivered by gravity, depending on the height the syringe is placed above the infant, or by manually pushing on the syringe. Milk can be administrated by nurses or by the parents after a learning period.

In this observational study, we would like to compare the preterm infants' behavioral during these different naso or oro gastric feeding modes by observing well-being signs and withdrawal signs (Dsilna grid) on video settings.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • Hospitalized at the University Hospitals of Strasbourg during October 2024 and October 2025
  • Needing nasogastric tube feeding during at least 4 days
  • With parents (legal representants) having expressed their agreement with the use of video recording in the framework of the current study

排除标准

  • ORL malformations
  • Neurological dysfunction
  • Sedated infant

结局指标

主要结局

Comparing the tolerance of these different types of food (gravity versus pushing the seringue), based on the child's behavioral and physiological signs of well-being.

时间窗: 6 months

Observation of preterm infants during and after naso/oro gastric tube feeding on videos to record well-being and withdrawal signs like classified in the Dsilna grid every 4 minutes.

次要结局

  • - Well-being and withdrawal signs by the Dsilna grid : comparison of manual methods versus electric syringe administration(6 monts)
  • - Well-being and withdrawal signs by the Dsilna grid : comparison during administration by parents or nurses(6 monts)

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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