Investigating the Effect of Held Position During Kangaroo Care on Physiological Parameters of Premature Infants - A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mean cerebral NIRS values over KMC session
研究概览
简要总结
The goal of this superiority crossover randomised controlled trial is to investigate whether there is an optimal position at which to perform kangaroo mother care (KMC) in extremely preterm infants in the NICU. The main question it aims to answer is: 1) is there an optimal position for an infant to be held during KMC and 2) to optimise benefits for infants receiving KMC. Participants will be: 1) randomised into two groups which determine which angle they will start at first, 2) assessed over two hour-long sessions on different days with a change in the angle at the 30 minute point, 3) monitored using a Massimo NIRS machine which will record oxygen saturations, cerebral NIRS values and heart rates, and 4) monitored for any episodes of desaturations and bradycardias during this time. Participants will then be assessed beginning with the the other angle first on a different day. The researchers will then compare the two groups to see if being held at a 30 degrees during KMC is superior to being held at 60 degrees in terms of physiological stability.
详细描述
In this proposed study the investigators will examine whether there is an optimal position in which to perform KMC. This will be performed by evaluating cerebral oxygenation with near infrared spectroscopy (NIRS). Cerebral Near-Infrared Spectroscopy (NIRS) is used as a non-invasive assessment of cerebral oxygenation and cerebral hemodynamics. NIRS gives an estimation of the regional cerebral tissue oxygenation via a probe attached to the baby's forehead. It is minimally invasive and won't interrupt any of baby's cares or interrupt time with parents. The investigators will use NIRS to specifically examine whether there is a difference in physiological parameters between being held when the Mother/Father is at a 30 degree or 60 degree angle on the bedside recliner and whether better oxygenation is associated with one position over another. Currently there are no studies assessing the optimal position to carry out KMC in neonatal units. This study proposes to help answer a question which has not yet been answered in the literature.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 28 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ex-premature infants who are a minimum of 28 weeks corrected gestational age
- •Minimum weight at assessment for entry to study 600g
- •Signed informed consent form
排除标准
- •Corrected gestational age under 28 weeks
- •Known neurological anomalies (not intraventricular Haemorrhage)
- •Known orthopaedic conditions
- •Known chromosomal anomalies
结局指标
主要结局
Mean cerebral NIRS values over KMC session
时间窗: 2 hours in total per infant
Mean cerebral NIRS values over the KMC session at the two different angles
次要结局
- Mean peripheral saturation values over KMC session(2 hours)
- Mean heart rate values over KMC session(2 hours)
- Number of Desaturations less than 80% for > 20 secs over KMC session(2 hours)
- Number of bradycardias <100bpm over KMC session(2 hours)
研究者
Dr. Gene Dempsey
Professor
University College Cork