Patterned Experience for Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 4
- 主要终点
- Neurobehavioral Assessment of the Preterm Infant (NAPI)
研究概览
简要总结
The PEPI study is designed to provide a patterned feeding experience. By using a regularly occurring and necessary caregiving event, feeding, as the vehicle for the patterned experience, the intervention should be effective at promoting and reinforcing neuronal growth and connections that are critical for neurobehavioral and cognitive function while at the same time being cost effective in its delivery.
详细描述
Infants will be randomly assigned to a study group or control group. The research study will last for approximately twenty four months. Infants will have daily assessments while in the hospital and three study visits after hospital discharge. All post-discharge visits will occur in an out patient hospital setting. During the first days of life, study staff will start observing infant's development by using assessment tools. Lab samples include one blood sample taken when other blood is being collected in the first days of life and one saliva sample when the infants starts bottle feeding.
When tube feedings are started in the study group, caregivers (nurses, parents or research staff) will gently place hands on the infant while in the incubator (ill babies) or bundled outside the incubator. If the infant is in the control group, they will receive standard tube feeding care.
When oral feedings are started in the study group, the infant will have an opportunity at every feeding to be breast or bottle fed while being held. If unable to complete the entire feeding orally, the rest will be tube fed.
If the infant is in the control group, feeding opportunities will be decided by the medical team providing care.
All infants will be observed during oral feedings twice a week while in the hospital. Study staff will watch heart rate, sucking activity (a sensor on the chin) and level of wakefulness.
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
- Single (Outcomes Assessor)
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
- •Infants born ≤ 32 weeks gestation
排除标准
- •Infants will be excluded if the infant has gastrointestinal, craniofacial, cardiovascular, neuromuscular, and/or genetic defects
结局指标
主要结局
Neurobehavioral Assessment of the Preterm Infant (NAPI)
时间窗: Birth, Transition to by mouth feeding, hospital discharge, 2 mo corrected age
Used as a measure of neurobehavioral development.
次要结局
- Sucking activity(Changes from an average age of 33 weeks postmenstural age to an average age of 38 weeks postmenstural age.)
- Bailey Scale of Infant Development (BSID), 3rd edition(6 and 24 months corrected age)
- Heart rate variability (low frequency:high frequency ratio)(Changes from an average age of 33 weeks postmenstural age to an average age fo 38 weeks postmenstural age.)