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临床试验/NCT01787019
NCT01787019已完成2 期

Initiation of Oral Feeding at 30 Versus 33 Weeks Postmenstrual Age

The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2013年1月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
66
试验地点
1
主要终点
Postmenstrual age at full oral feeding

研究概览

简要总结

The purpose of the study is to determine if earlier initiation of oral (by mouth as opposed to tube) feedings in premature infants results in earlier attainment of full oral feedings and/or discharge.

详细描述

Infants will be enrolled and randomized at 30 0/7 weeks postmenstrual age. The Earlier Oral Feeding group will initiate oral feedings at 30 0/7 weeks postmenstrual age. The Later Oral Feeding group will initiate oral feedings at 33 0/7 weeks postmenstrual age. The number of oral feeding attempts will be advanced according to a feeding progression protocol for both groups. Successful completion of a feeding is defined as oral completion of the full volume of a feeding within 30 minutes, without a bradycardic episode (heart rate <100 beats per minute) or desaturation (oxygen saturation decrease >5% from baseline values). If infant does not successfully complete >95% of the total prescribed volume of a feeding, the remainder of the volume will be supplied via gastric tube. All oral feedings will be performed by bedside nurses, or by a parent with observation by the nursing staff, with continuous cardiorespiratory and pulse oximetry monitoring. Individual oral feeding attempts for both groups will continue until one of the following occurs despite appropriate pacing of the feeding: 1) the feeding is completed 2) feeding duration of 30 minutes 3) adverse event during a feeding [multiple bradycardic episodes (3 episodes of heart rate <100 beats per minute), bradycardia with choking episode, single severe bradycardia (heart rate <60)]. If the infant experiences an adverse event during an oral feeding attempt, oral feeding attempts will be held for 2 days.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 7 Weeks(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Gestational age <= 29 weeks at birth
  • •Tolerating enteral feedings for at least 3 days before 30 weeks postmenstrual age

排除标准

  • •Neurologic, cardiac, respiratory, or gastrointestinal disorders that interfere with oral feeding

研究组 & 干预措施

30 weeks

Experimental

initiation of oral feedings at 30 weeks

干预措施: Oral feeding (Other)

33 weeks

Active Comparator

initiation of oral feedings at 33 weeks

干预措施: Oral feeding (Other)

结局指标

主要结局

Postmenstrual age at full oral feeding

时间窗: until hospital discharge (typically 36 weeks postmenstrual age)

defined as the infant orally consuming the volume of formula/breastmilk as prescribed by the attending physician without requiring gavage feedings for 2 days

次要结局

  • growth between enrollment and 36 weeks postmenstrual age(until hospital discharge (typically 36 weeks postmenstrual age))
  • postmenstrual age at discharge(until hospital discharge (typically 36 weeks postmenstrual age))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kathleen Kennedy

Professor of Pediatrics

The University of Texas Health Science Center, Houston

研究点 (1)

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