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临床试验/NCT06794164
NCT06794164招募中不适用

Immediate Skin-To-Skin Care For Preterm Infants After Birth

Medical University of Graz1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
vital parameter: Heart rate

研究概览

简要总结

The standard procedure in our centre for preterm neonates is to enable skin-to-skin (SSC) contact within 24 hours after birth. As early SSC immediately after birth might provide numerous positive effects for mothers and their preterm neonates, the objective of this study is to evaluate the feasibility, the safety and the effect of skin-to-skin contact immediately after birth in preterm neonates born with gestational age between 26+0 and 32+0 weeks.

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
0 Minutes 至 30 Minutes(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Gestational age between 26+0 and 32+0 weeks
  • •Written parental informed consent

排除标准

  • •No intention of full life support
  • •Severe congenital malformation

研究组 & 干预措施

Early skin-to-skin care

Experimental

Intervention group

干预措施: skin to skin care (Procedure)

Standard care group

Active Comparator

Control group

干预措施: Standard Care (in control arm) (Procedure)

结局指标

主要结局

vital parameter: Heart rate

时间窗: during the first 2 hours after birth

vital parameter: Oxygen saturation

时间窗: during the first 2 hours after birth

in percent

vital parameter: blood pressure

时间窗: during the first 2 hours after birth

systolic, diastolic and mean blood pressure

vital parameter: Temperature

时间窗: during the first 2 hours after birth

次要结局

  • blood sugar(1 hour after birth)
  • FiO2 (Fraction of inspired oxygen)(during first 2 hours after birth)

研究者

发起方
Medical University of Graz
申办方类型
Other
责任方
Sponsor

研究点 (1)

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