Continuous Monitoring of Body Temperature in Neonates During Skin-to-skin Care Immediately After Cesarean Section (MonT Neo) - a Prospective Observational Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- body temperature
研究概览
简要总结
The objective of this prospective observational pilot study is to apply the adhesive thermometer SteadyTemp® (SteadySense GmbH, Graz, Austria) in term neonates to monitor their body temperature non-invasively and continuously during skin-to-skin care with their mothers after Cesarean section and to compare these data with the one-time manual measurement of rectal body temperature as gold standard.
详细描述
Primary aim: To apply the adhesive thermometer SteadyTemp® (SteadySense GmbH, Graz, Austria) in term neonates in the right axillary area immediately after birth and to monitor their body temperature continuously during skin-to-skin care with their mothers after Cesarean section for 15 minutes.
Secondary aim
- To compare the body temperature with manually measured rectal temperature (single measurement).
- To examine the skin condition under the adhesive patch after 15 minutes of application using the Neonatal Skin Condition Scale (NSCS)17.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Term neonates after caesarean section receiving skin-to-skin care immediately after birth
- •Parental written informed consent
排除标准
- •Preterm birth
- •Need for respiratory support after birth
- •No decision to conduct full life support
- •No written informed consent
- •Congenital malformation
结局指标
主要结局
body temperature
时间窗: up to 15 minutes after birth
body temperature continuously measured with SteadyTemp® (SteadySense GmbH, Graz, Austria)
次要结局
未报告次要终点