The Effects of Skin-to-Skin Contact on Newborn Temperature, Initial Bath and Early Breastfeefing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 325
- 试验地点
- 2
- 主要终点
- Time to temperature stabilization until initial bath
研究概览
简要总结
This study will compare standard methods of stabilizing a newborn's temperature after birth with mother-infant skin-to-skin contact for stabilizing newborn temperature. The study will look at the effects of each warming method on the timing of newborns' initial bath and the effects on newborn initiation and percent weight loss by discharge.
The study will use a randomized controlled trial (RCT) design to test a clinical intervention at TriHealth Good Samaritan Hospital. Study participants will be randomized to the intervention group (IG), which will implement mother-baby Skin-to-Skin (STS) immediately after vaginal birth, or to the control group (CG), which will receive standard care for newborn and mother immediately after vaginal birth.
This study will test the hypothesis that mother-baby STS contact implemented immediately after delivery for a minimum of the newborn's first 60 minutes and with a resumption of STS (if a 15-minute break in STS occurs at some point after the first hour) until the newborn's temperature stabilizes after the initial bath will result in:
- Improved newborn temperature stability and thermoregulation for newborns whether breast or formula-fed.
- Initiation of effective breastfeeding behavior within 90 minutes of birth and the addition of at least one more breastfeeding within four hours of birth for breastfed newborns.
- Avoidance of newborn weight loss of 10% or greater.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Woman in labor presenting with
- •An uncomplicated pregnancy
- •Full-term gestation: 38 0/7 weeks
- •Single gestation
- •Vertex presentation
- •Plans to deliver without general anesthesia
- •Likelihood of a vaginal delivery
排除标准
- •A complication of pregnancy at the time of admission
- •An inability to speak or understand English language
- •Preterm gestation: 37 6/7 weeks
- •A multiple gestation
- •Non-vertex presentation
- •Plan for delivery with general anesthesia
- •Planned Cesarean delivery
研究组 & 干预措施
Skin to Skin Contact
implement mother-baby Skin-to-Skin contact immediately after vaginal birth
干预措施: Skin-to-Skin Contact (Behavioral)
Standard of Care
standard care for newborn and mother immediately after vaginal birth
结局指标
主要结局
Time to temperature stabilization until initial bath
时间窗: one minute to 60 minutes after birth
次要结局
- Time required for temperature re-stabilization after initial bath(on minute after initial bath until baby reaches desired temperature)
研究者
Rachel Baker
Nurse Researcher
TriHealth Inc.
