Reduced Infant Response To A Routine Care Procedure After Glucose 25% Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 180
- 主要终点
- Reduced infant response to a routine care procedure after glucose 25% analgesia
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 for procedural pain on infant pain responses during a subsequent care giving procedure.
详细描述
Pain in the newborn and young infant is a source of stress for the infant, family and care providers.
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. Our objective is to determine the effect of glucose 25% analgesia 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
- 主要目的
- Prevention
- 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%
180 healthy babies born term in the Baruch Padeh Medical Center, Poriya.
There will be three study groups:
Study Group: 60 newborn infants who will receive 1cc 25% Glucose, 2-3 minutes prior red-reflex examination.
Base line (control) Group 1: 60 newborn infants who will receive 1cc Water for Injection (WFI), 2-3 minutes prior red-reflex examination.
Base line (control ) Group 2: 60 newborn infants who will not receive neither glucose nor Water for Injection (WFI), 2-3 minutes prior red-reflex examination
干预措施: Glucose 25% (Drug)
结局指标
主要结局
Reduced infant response to a routine care procedure after glucose 25% analgesia
时间窗: 30 minutes
An observer nurse will focus on the infant's facial expression. A score between 0 and 3 will be assigned for each of the three facial expression indicators. For physiological data, infants will be monitored for changes in heart rate and oxygen saturation using a transcutaneous pulse oximeter. A score between 0 and 3 will be assigned for each of the physiological indicators
次要结局
未报告次要终点
研究者
Shay Barak
Senior Neonatologist
The Baruch Padeh Medical Center, Poriya