Breast Feeding Analgesia in Preterm Infants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Behavioral Indicators of Infant Pain (BIIP) - total score
研究概览
简要总结
The purpose of this study is to compare the effects of mothers' breastfeeding with the effects of pacifier sucking on preterm infant biobehavioural responses during and immediately after a painful procedure
Hypothesis:
- When breast fed by their mothers during blood collection, preterm infants will show less pain reaction than when sucking on a pacifier.
- Following breast feeding during the blood collection, mothers will find no differences in their infants' breast feeding ability.
详细描述
Research Method:
In a within subjects, randomized, cross-over design, 50 stable preterm infants born between 30-36 weeks gestational age will be studied. Infants will be randomized to two interventions which will take place during two separate 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 feeding condition, infants will be held and then breast fed by their mother 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
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 3 Days 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •born between 30-36 weeks gestational age
- •breastfeeding
- •mother has fluent English
排除标准
- •CNS injury
- •congenital anomaly
- •active infection
- •has had surgeries or analgesics/sedatives in last 72 hours
- •history of maternal drug exposure
结局指标
主要结局
Behavioral Indicators of Infant Pain (BIIP) - total score
Heart Rate
Videotaped and recorded at Baseline, Lance and Recovery:
次要结局
- Videotaped and Recorded at Baseline, Lance and Recovery:
- Hand Movements
- Sleep/Wake States
- Samples taken at baseline, lance and recovery
- Salivary Cortisol sample
- Recorded before the breast feeding intervention and at 24 hours following:
- Preterm Infant Breastfeeding Behavior Scale