The Holding Pilot Study: Feeding Analgesia in Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Videotaped and recorded at Baseline, Lance and Recovery:Neonatal Facial Coding System - total facial score; Heart Rate
研究概览
简要总结
The purpose of this study is to compare the effects of mothers' skin-to-skin holding during feeding via a soother trainer with the effects of pacifier sucking on preterm infant biobehavioural responses during and immediately after a painful procedure
Hypothesis:
- When held by their mothers during blood collection, preterm infants will show less pain reaction than when sucking on a pacifier.
- Following holding during the blood collection, mothers will find no differences in their infants' feeding ability.
详细描述
Research Method:
In a between subjects, randomized design, 20 stable preterm infants born between 30-35 weeks gestational age will be studied. Infants will be randomized to one of two interventions which will take place during blood collections that are required for clinical management. For the standard care condition, infants will remain in their isolettes and will be positioned in prone and given a pacifier to suck on throughout the blood collection. For the holding condition, infants will be held skin-to-skin by their mothers and given breast milk using a soother trainer during the blood collection.
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
- 3 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Born between 30-35 weeks gestational age
- •Mother has fluent English
排除标准
- •CNS injury
- •congenital anomaly
- •active infection
- •has had no surgeries or analgesics/sedatives in last 72 hours
- •history of maternal drug exposure
结局指标
主要结局
Videotaped and recorded at Baseline, Lance and Recovery:Neonatal Facial Coding System - total facial score; Heart Rate
次要结局
- Videotaped and Recorded at Baseline, Lance and Recovery:Hand Movements; Sleep/Wake States
- Samples taken at baseline and recovery;Salivary Cortisol sample