Reduced Infant Response to a Routine Care Procedure After Glucose 25% Analgesia in Comparison to Materna RTF Stage 1
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- less discomfort
研究概览
简要总结
Glucose has analgesic and calming effects in newborns. To date, it is not known whether the beneficial effects extend to care giving procedures that are performed after painful procedures. The investigators objective is to determine the effect of glucose 25% analgesia in comparison to Materna RTF Stage 1 for procedural pain on infant pain responses during a subsequent care giving procedure.
详细描述
During hospitalization, a neonate undergoes a number of necessary procedures that may be either painful or cause discomfort to the baby.
Pain experienced during the neonatal period is known to have long term effects on the baby.
The red-reflex test is a routine examination performed on a neonate after birth and once again before discharge from the hospital. The examination causes discomfort to the infant Glucose has analgesic and calming effects in newborns. To date, it is not known whether the beneficial effects extend to care giving procedures that are performed after painful procedures. The investigators objective is to determine the effect of glucose 25% analgesia in comparison to Materna RTF Stage 1 for procedural pain on infant pain responses during a subsequent care giving procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Day 至 16 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Full term above 37 weeks gestation.
- •Normal birth-weight, healthy infants
- •Males and Females
- •Whose parents have signed the informed consent form
排除标准
- •Premature born below 37 weeks
- •Chromosomal abnormalities or congenital malformation.
- •Suffering neurological imbalance
- •Inability of oral feeding
研究组 & 干预措施
glucose 25%
1 ml of glucose once
干预措施: Glucose 25% (Drug)
infant formula
Materna RTF stage 1
干预措施: Materna RTF Stage 1 (Dietary Supplement)
Water for Injection
1 ml Water for Injection (WFI), 2-3 minutes prior red-reflex examination
干预措施: Water for Injection (Other)
结局指标
主要结局
less discomfort
时间窗: immediate, during examination (day 1)
the infant will experience less pain during examination
次要结局
未报告次要终点
研究者
Shay Barak
Senior Neonatologist, Neonatal Intensive Care
The Baruch Padeh Medical Center, Poriya