Its an Interventional Study That Will Evaluate the Effect of Different Doses of Sucrose 24% on Neurodevelopmental Outcome of Preterm Infants
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- neurodevelopmental outcomes
研究概览
简要总结
The purpose of this study is to determine the effect of sucrose 24% for pain prevention on preterm infants. Our hypothesis is that repeated doses of sucrose 24%, given prior to painful procedure,do not impair neurodevelopmental outcomes of preterm infants
详细描述
preterm infants born at 27-33 weeks gestational age at Sheba Medical Center will be recruited for this study. Prior to invasive procedure infants will be treated with pacifier and swaddling as recommended by the American Academy of Pediatrics and Canadian Pediatric Society.
Group 1.Will be treated with Sucrose 24% 0.1-0.5ml on the anterior pat of the tongue 1-3 min prior to invasive procedure.
Group 2. Similar to group 1 but breast milk or formula will replace Sucrose.
Number of invasive procedures/day will be documented
General Movements by Prechtel will be used for developmental assessment at 2,4,6 weeks after birth and at 14-16 weeks corrected age
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 27 Weeks 至 33 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •preterm infants born at SMC
排除标准
- •need for intubation
- •need for sedation
- •abnormal head ultrasound
- •genetic abnormalities
- •necrotizing enterocolitis
- •other painful conditions other than routine blood exams
研究组 & 干预措施
Formula or Breast Milk
Breast milk or formula prior to every painful procedure.
干预措施: Formula or breast milk (Drug)
Multiple doses of sucrose
Infants in this group will be treated with Sucrose 24% 0.5-1ml on the anterior pat of the tongue 1-3min prior to every invasive procedure
干预措施: multiple doses of sucrose (Drug)
结局指标
主要结局
neurodevelopmental outcomes
时间窗: at 6 month corrected age
Griffith mental developmental scaled (gross and fine motor, language, performance, social) and General movements by Prechtel
次要结局
- neurodevelopment(at 15 weeks corrected age)
研究者
Dr. Iris Morag
Staff Neonatologist
Sheba Medical Center