跳至主要内容
临床试验/NCT04368767
NCT04368767已完成不适用

A Pilot Randomized Controlled Trial of the Effects of Daily Skin-to-skin Contact Compared to Standard Care on the Stress Responses of Late Preterm Infants in the First Week of Life

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2020年8月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
2
主要终点
Stress biomarkers

研究概览

简要总结

Late preterm infants are at risk of experiencing inadequate glycogen stores with immature glucose metabolism and increased adenosine triphosphate (ATP) degradation, which indicates cellular increased and stress. Processes mediating infant acute/chronic stress symptoms and their biochemical effects have not been adequately investigated. Skin-to-skin contact (SSC), also known as Kangaroo Mother Care (KMC), is as an intervention that activates mechanisms of energy preservation that decrease stress in preterm infants. SSC has been shown in numerous clinical trials to reduce mortality and morbidity by stabilization of breathing, thermal regulation, oxygen saturation, and heart rate. SSC also reduces behavioral distress during painful and stressful procedures and improves breast-feeding parent bonding. However, little is known about how SSC affects biomarkers of stress and energy expenditure in late preterm infants in the first week of life.

The aim of this pilot randomized controlled trial is to evaluate changes in biomarkers of stress, stress modulation and energy expenditure in late preterm infants who receive two hours of continuous SSC care or two hours of lying undisturbed in an incubator administered daily for 3 consecutive days in the first week of life, and to provide preliminary data for future research comparing the effects of usual incubator care with prolonged SSC on stress biomarkers in preterm infants.

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

性别
All
接受健康志愿者

入选标准

  • Infants between 34 weeks and 0/7 days through 35 weeks and 6/7 days gestational age
  • Medically stable as determined by a Neonatal Acute Physiology- Perinatal Extension SNAPPE -II (SNAPPE-II) score of less than 9
  • Mothers able to read and write English
  • Mothers have no medical contraindications to holding their infant in SSC for up to 2 hours

排除标准

  • Surgery in the first week of life
  • Intraventricular hemorrhage (IVH) of grade 3 or 4
  • Opioids, benzodiazepines, muscle relaxants, phenobarbital, and/or dilantin
  • Plasma creatinine of >1 mg/dl
  • Severe cyanotic heart disease or severe respiratory distress
  • Abdominal wall or intestinal anomaly or injury (NEC)
  • Facial anomaly or other known chromosomal anomaly
  • Life-threatening congenital anomaly or are so critically ill that they are unlikely to survive or are receiving palliative care

结局指标

主要结局

Stress biomarkers

时间窗: Day 1

Compare group differences in measures of stress (i.e., salivary cortisol, urinary biomarkers of Hx, Xa, UA, and allantoin, and stress buffering (i.e., salivary oxytocin) between the intervention and usual care groups.

次要结局

  • Number of discomforting and stressful events for mother(Day 1)
  • Number of discomforting and stressful events for infant(Day 1)
  • Mother's Satisfaction with SSC(Day 3)
  • Change in stress biomarkers(pre and post the intervention on days 1, 2, and 3)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验