跳至主要内容
临床试验/NCT02143193
NCT02143193已完成不适用

The Effects of Skin-to-Skin Contact on Newborn Temperature, Initial Bath and Early Breastfeefing

Rachel Baker2 个研究点 分布在 1 个国家目标入组 325 人开始时间: 2011年8月最近更新:
适应症
干预措施

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:

  1. Improved newborn temperature stability and thermoregulation for newborns whether breast or formula-fed.
  2. 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.
  3. 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

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

Experimental

implement mother-baby Skin-to-Skin contact immediately after vaginal birth

干预措施: Skin-to-Skin Contact (Behavioral)

Standard of Care

No Intervention

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

发起方
Rachel Baker
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Rachel Baker

Nurse Researcher

TriHealth Inc.

研究点 (2)

Loading locations...

相似试验