NCT00713986已完成3 期
Non-Pharmacologic Interventions to Relief Pain in Healthy Newborns Submitted to Vaccination to Hepatitis B: a Comparison Between Skin-to-Skin Contact, Glucose 25% and Both of Them
Federal University of São Paulo0 个研究点目标入组 640 人开始时间: 2006年3月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 640
- 主要终点
- Neonatal pain scales: Neonatal infant pain Scale (NIPS), Neonatal Facial Coding System (NFCS) and Premature Infant Pain Profile (PIPP)
研究概览
简要总结
Acute procedural pain in neonates may be alleviated by non-pharmacological procedures. This study objective is to test the efficacy regarding pain attenuation of 3 interventions (skin-to-skin contact versus glucose 25% versus skin to skin associated to glucose 25) versus control in healthy newborn infants submitted to intra-muscular vaccination for Hepatitis B at 48-72 hours of life.
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
- None
入排标准
- 年龄范围
- 12 Hours 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Gestational age of 37 0/7 to 41 6/7 weeks.
- •Patients cared in rooming-in, with post-natal age of 12 to 72 hours of life.
- •Adequate for gestational age and healthy infants.
- •No other painful stimuli before study except for Vitamine K injection soon after birth.
- •Interval from last feeding between 30 and 60 minutes.
排除标准
- •Mothers that used opioid at gestation labor or birth.
- •Delivery under general anesthesia.
- •Apgar score less than seven in the 1st or 5th minute of life.
- •Neonates that received any venous, arterial, capillary or spinal puncture.
- •Any congenital malformation or CNS abnormality.
结局指标
主要结局
Neonatal pain scales: Neonatal infant pain Scale (NIPS), Neonatal Facial Coding System (NFCS) and Premature Infant Pain Profile (PIPP)
时间窗: before the pain procedure (atrest), during cleaning of the region, at injection, and 2 minutes after injection
次要结局
- Physiologic pain assessment variables: heart rate and oxygen saturation(before the pain procedure (atrest), during cleaning of the region, at injection, and 2 minutes after injection)
研究者
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