Standardization of Infants Heel Warming Before Capillary Blood Sampling - a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- Speed of blood sampling
研究概览
简要总结
Capillary blood sampling from the heel is often used in the treatment of infants admitted to neonatal intensive care (NICU). In Danish NICUs a heated blanket, a heated gel pad or a disposable glove with warm water are the methods most often used.
The purpose of this randomized controlled study is to investigate which of the mentioned heating methods ensures the best quality of the blood sample and provides the most gentle blood sampling for the infant.
详细描述
Some infants experience a difficult and painful blood sampling which can lead to bruised or swollen heels and a blood sample of poor quality. To minimize the risk of that, the infant's heel is heated before the procedure as described in standard GP42-A6 from The Clinical and Laboratory Standards Institute. However, no consensus exists on which heating method to use. The aim of this study is to compare three different heating methods in terms of which method can help reduce pain experienced by infants as well as increase the quality of the blood samples.
Infants (postmenstrual age ≥ 28 + 0) admitted to the NICU, Kolding Hospital and having a blood sample taken by a Biomedical Laboratory Scientist are invited to participate. A parental informed concent must be signed by both parents before participation.
Infants are randomized to one of the three heating methods: glove, blanket or gel pad.
The following blood sampling procedure is closely monitored to register data corresponding to the five outcome measures.
Furthermore the infants personal data, location of the infant during the procedure, surface temperature of the heel before and after heating, volume of sampled blood, sign of bruises and swelling as well as hematocrit are registered.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Also masked: Biomedical Laboratory Scientist
入排标准
- 年龄范围
- 2 Hours 至 77 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PMA (postmenstrual age) ≥ 28+0
- •Blood sampling performed by a Biomedical Laboratory Scientist
排除标准
- •GA (gestational age) ≥ 44+0
- •Weight > 6000 g
- •Coagulation related disorder
- •Severe illness/disorder
- •Heel is bruised or swollen
- •Parents not understanding written Danish language
结局指标
主要结局
Speed of blood sampling
时间窗: 10 minutes
µl blood/sec
Duration of blood sampling
时间窗: 10 minutes
Sec
次要结局
- Degree of squeezing the infants foot during blood sampling(1 minute)
- Hemolysis index for potassium of the blood sample(2 hours)
- Number of heel punctures required to obtain the blood sample(10 minutes)
- ComfortNeo score of the infant during the blood sampling(20 minutes)