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临床试验/NCT02024828
NCT02024828已完成不适用

Feeding Readiness in Preterm Infants

Children's Hospital Medical Center, Cincinnati1 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2006年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
109
试验地点
1
主要终点
Feeding Performance

研究概览

简要总结

The purpose of this study was to test the effect of four randomly assigned approaches to oral feeding transition on feeding outcomes in preterm infants.

详细描述

The study is completed.

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 32 Weeks(Child)
性别
All
接受健康志愿者
否

入选标准

  • •the infant's gestational age at birth was less than 32 weeks; 2) the infant was receiving enteral feedings every three hours; 3) the infant was able medically to feed orally by 32 weeks post-menstrual age (PMA); and 3) the parents gave consent for the infant's participation.

排除标准

  • •they were unable to begin oral feeding at 32 weeks PMA due to gastrointestinal, craniofacial, cardiovascular, neuromuscular, and/or genetic defects; 2) had surgical necrotizing enterocolitis; or 3) needed ventilator support, including nasal continuous positive airway pressure (CPAP), beyond 32 weeks PMA. Infants receiving oxygen by cannula were included.

研究组 & 干预措施

Early/Slow

Experimental

Infants were offered oral feedings beginning at 32 weeks PMA. They were offered 2 oral feedings per day for 3 days (Days 1-3). The number of oral feedings offered per day increased by 1 feeding every other day until day 14 when they were offered 8 oral feedings each day (Days 4-5, 3 oral feeds offered; Days 6-7, 4 oral feeds offered; Days 8-9, 5 oral feeds offered; Days 10-11, 6 oral feeds offered; Days 12-13, 7 oral feeds offered; Day14, 8 oral feeds offered). Any feedings not offered orally were provided by gavage.

干预措施: Early/Slow (Other)

Early/Fast

Experimental

Infants were first offered oral feedings beginning at 32 weeks PMA. They were offered 8 oral feedings every day, at each of 8 scheduled daily feedings.

干预措施: Early/Fast (Other)

Late/Slow

Experimental

Infants were offered oral feedings beginning at 34 weeks PMA. They were offered 2 oral feedings per day for 3 days (Days 1-3). The number of oral feedings offered per day increased by 1 feeding every other day until day 14 when they were offered 8 oral feedings each day (Days 4-5, 3 oral feeds offered; Days 6-7, 4 oral feeds offered; Days 8-9, 5 oral feeds offered; Days 10-11, 6 oral feeds offered; Days 12-13, 7 oral feeds offered; Day14, 8 oral feeds offered). Any feedings not offered orally were provided by gavage.

干预措施: Late/Slow (Other)

Late/Fast

Experimental

Infants were offered oral feedings beginning at 34 weeks PMA. They were offered 8 oral feedings every day, at each of 8 scheduled daily feedings.

干预措施: Late/Fast (Other)

结局指标

主要结局

Feeding Performance

时间窗: One oral feeding a day for 14 days

Includes 3 components: Proportion consumed (volume taken/volume ordered), rate of consumption (volume consumed/minutes of feeding); proficiency (volume taken in first 5 minutes of feeding/volume ordered)

次要结局

  • Clinical outcomes(Participants will be followed for the duration of the hospital stay, an expected average from starting oral feedings of 3 weeks)
  • Post-discharge feeding(2 weeks after discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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