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临床试验/NCT00365703
NCT00365703已完成不适用

Nasogastric Tube vs. Orogastric Feeding Tube in Preterm Infants: Which is Best?

Hillel Yaffe Medical Center2 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2006年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
115
试验地点
2
主要终点
The mean post conceptual age at which the infant is fed orally only.

研究概览

简要总结

The purpose of this study is to find out which method (nasogastric vs. orogastric) of feeding tube for premature infants results in earlier only oral feeding.

详细描述

Preterm infants, even as young as 23 weeks gestational age, can be fed enterally at the first week of life. Coordination of sucking and swallowing, and coordination of both and breathing is necessary for efficient and safe oral feeding, and is not well established before the 35th week gestational age. That is why tube feeding is essential for preterm infants younger than that age.

There is no consensus regarding the best way for the feeding tube, i.e. oral vs. nasal, and whether placing the tube should be continuous or intermittently. Nasogastric tube has been associated with vagal responses. Both tubes may cause gastric perforation.

Development and function of oral feeding has been described. It is known that non-nutritive sucking and early introduction of oral feeding accelerate the transition from tube feeding to oral feeding. It is suggested that the preterm infant may experience a maturational lag in vagal function related to ingestive needs, which may contribute to continued feeding difficulties and may be a measurable marker of subtle neurodevelopmental problems. Both oral and nasal feeding tube may interfere with establishment of efficient oral feeding. The purpose of this study is to see whether there is a difference between oral and nasal tube feeding, regarding the institution of oral feeding.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
— 至 4 Months(Child)
性别
All
接受健康志愿者

入选标准

  • All preterm infants, born during one year, who required tube feeding, and later discharged from neonatal intensive care unit.

排除标准

  • Infants who died during hospitalization
  • Infants with severe neurologic deficit (e.g. after Sarnat II-III asphyxia, or as a part of a syndrome
  • Infants with gastrostomy
  • Infants who were transferred to another hospital for any reason (e.g. heart surgery)

结局指标

主要结局

The mean post conceptual age at which the infant is fed orally only.

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other Gov

研究点 (2)

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