Breastmilk or Oral Sucrose Solution in Preterm Neonates for Procedural Pain: a Randomized, Controlled Study
试验速览
- 阶段
- 3 期
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Decrement from 80 to 40% of frequency of DAN's scale score superior to 1 using breastmilk instead of oral sucrose
研究概览
简要总结
Hypothesis: Breastmilk has a more powerful analgesic effect than oral sucrose to avoid procedural pain in preterm neonates.
The objective is to test this hypothesis in a randomized, controlled study using a standardized and validated pain scale (DAN). The sample size is 21 preterm infants in each two groups. The main end point is a reduction of the risk to have a DAN superior to 1 from 80% with oral sucrose to 40% with breastmilk.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Days 至 10 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm neonates born before 27 and 29+6 weeks GA
- •blood sampling procedure
- •obtention of parental consent
排除标准
- •congenital malformation
- •intravenous continuous analgesia
- •contraindications to feed
- •high grade intracerebral hemorrhage
研究组 & 干预措施
sucrose
This group will receive oral sucrose for procedural pain
干预措施: Oral Sucrose (Other)
breastmilk
this group will receive breastmilk as analgesic product to avoid procedural pain
干预措施: Breastmilk (Other)
结局指标
主要结局
Decrement from 80 to 40% of frequency of DAN's scale score superior to 1 using breastmilk instead of oral sucrose
时间窗: One time during day 3 or 4 then day 7 to 10
次要结局
未报告次要终点