NCT02508571已完成不适用
The Effects of Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- Days From Start to Independent Oral Feeding
研究概览
简要总结
This is randomized controlled trial investigating the effects of direct swallowing training and oral sensorimotor stimulation in preterm infants on oral feeding performance.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Allocation is concealed from all investigators, nurses, doctors, and parents, with the sole exception of the occupational therapists, who provided the interventions.
入排标准
- 年龄范围
- 22 Weeks 至 31 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants : before 32+0 weeks gestation
- •Infants who are receiving full tube feeding (more than 120 ml/kg/day)
- •Infants who discontinue of nasal continuous positive airway pressure before postmenstrual age 33+0 weeks
- •'Feeders and growers'
- •The parents of the subject voluntarily sign the informed consent
排除标准
- •Major congenital anomalies : face, central nervous system, gastrointestine, heart, etc
- •Gastrointestinal complications
- •Chronic medical complications : Intraventricular hemorrhage ≥ Grade III, periventricular leukomalacia, surgical necrotizing enterocolitis
结局指标
主要结局
Days From Start to Independent Oral Feeding
时间窗: From date of starting oral feeding until the date of independent, full oral feeding, an expected average of 3 weeks
Days from start to independent oral feeding (independent oral feeding, 2 days in a row with no adverse events that do not self-resolve - The first successful day)
次要结局
- Days From Start to First Full Oral Feeding(From date of starting oral feeding until the date of first full oral feeding, an expected average of 2 weeks)
- Days From Start to Complete Full Oral Feeding(From date of starting oral feeding until the date of complete oral full feeding, an expected average of 3-4weeks)
- Overall Transfer(Total number of assessment : 3 times ( 1. starting oral feeding, 2. volume of oral feeding/total feeding volume x 100 = 50%, 3. volume of oral feeding/total feeding volume) x 100 = 100%)
- Proficiency(Total number of assessment : 3 times ( 1. starting oral feeding, 2. volume of oral feeding/total feeding volume x 100 = 50%, 3. volume of oral feeding/total feeding volume) x 100 = 100%)
- Rate of Transfer(Total number of assessment : 3 times ( 1. starting oral feeding, 2. volume of oral feeding/total feeding volume x 100 = 50%, 3. volume of oral feeding/total feeding volume) x 100 = 100%)
- Volume Loss(Total number of assessment : 3 times ( 1. starting oral feeding, 2. volume of oral feeding/total feeding volume x 100 = 50%, 3. volume of oral feeding/total feeding volume) x 100 = 100%)
- Neonatal Oral Motor Assessment Scale (NOMAS)(Total number of assessment : 2 times ( 1. 3-5 days after starting oral feeding, 2. within 3 days after stopping intervention))
- Length of Hospital Stay(From date of admission until the date of discharge, through study completion, expected average days of 3 month)
- Bayley Scales of Infant and Toddler Development, Third Edition(Corrected age 18-24 months)
- Korean Version of MacArthur-Bates Communicative Development Inventories (K M-B CDI)(postnatal age 36±2 months)
- Korean-Wechsler Preschool and Primary Scale of Intelligence (K-WPPSI)-Fourth Edition.(aged 4:00~4:11 years)
- Korean Developmental Screening Test(postnatal age 48±3 months)
- Strengths and Difficulties Questionnaire(postnatal age 48±3 months)
- Behavioral Pediatrics Feeding Assessment Scale (BPFAS)(postnatal age 48±3 months)
研究者
Ee-Kyung Kim
Clinical associate professor
Seoul National University Hospital
研究点 (1)
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