Trial of Patterned Oral Somatosensory Entrainment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 210
- 试验地点
- 10
- 主要终点
- The length of time to reach 100% full oral feeds
研究概览
简要总结
The primary hypothesis is that the preterm infants (26 0/7 to 30 6/7 weeks gestational age) who undergo the NTrainer System® training will transition to full oral feeds faster than the control group (i.e. the study group will be superior to the control).
The secondary hypothesis is that the infants in the NTrainer System® experimental group will have shorter lengths of stay.
详细描述
Patterned Oral Somatosensory Intervention
The interventions (Treatment vs Control) will be initiated simultaneously with tube (gavage) feeds as early as 30 weeks post-menstrual age. Before and during each training session the infant will be evaluated for the following criteria:
Criteria for Initiation of each intervention:
- Not on continuous vasopressor medications
- Feeding in previous 48 hours.
- Not mechanically ventilated. If the infant is on CPAP or Nasal cannula >2 liters per minute, then the FiO2 must be <40%.
Criteria for Exiting an Intervention Session:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 26 Weeks 至 31 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Birth Gestational age 26 0/6 - 30 6/7 weeks
排除标准
- •Chromosomal abnormalities
- •Congenital anomalies included but not limited to
- •craniofacial malformation
- •cyanotic congenital heart disease
- •gastroschisis
- •omphalocele
- •diaphragmatic hernia or other major gastrointestinal anomalies
- •Major neurological anomaly
- •Infants with history of surgical necrotizing enterocolitis (stage III)
- •Infants with vocal cord paralysis
- •Infants with neonatal seizures
- •Infants with meningitis at time of enrollment
- •Infants who are nippling all feeds at the time of enrollment
- •Infants with narcotic abstinence syndrome (NAS)
- •Infants enrolled in another clinical study
结局指标
主要结局
The length of time to reach 100% full oral feeds
时间窗: 14 days on average
Time (in days) from initiation of oral feedings to the first oral intake that results in 100% oral feeding (definition of 100% oral feeding: no gavage supplementation and taking at least 120 milliliters per kilogram per day for 48 consecutive hours of breast milk, fortified breast milk or preterm formula as ordered by the child's physician.
次要结局
- The reduction in length of stay as a result of therapy(24 days on average)