Evaluation of Cerebral Oxygenation Results in Premature Infants: Kangaroo Care and Facilitated Tucking Example
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- The first sub-purpose Outcome: physiological parameters of the premature infant- SpO2 level
研究概览
简要总结
The general purpose of this project is; Evaluation of cerebral oxygenation results in premature infants.
These results will be evaluated in two different applications. The first practice and the first sub-aim of the study is to determine the effect of kangaroo care on cerebral oxygenation (rSO2) in premature infants.
The second application and purpose is to determine the effect of giving the infant the facilitated tucking position by hand and the nesting bed on the cerebral oxygenation (rSO2) of the infant during the heel blood collection process.
The study will be conducted between December 2020 and December 2021 at Level III NICU at the Medical Faculty Hospital in Konya.
详细描述
The general purpose of this project is; To determine the effect of kangaroo care and facilitated tucking position on cerebral oxygenation (rSO2) in premature infants.
In this context, the study has two sub-objectives. First sub purpose; to determine the effect of kangaroo care application given to premature inafants hospitalized in the NICU with the mother on cerebral oxygenation (rSO2), physiological parameters (heart rate, peripheral oxygen saturation (SpO2) and respiratory rate) and comfort / comfort levels.
This study was designed as a single blind, parallel group, pre-test and post-test randomized controlled trial.
First sub purpose; total sample size was determined as 40 preterm babies (20 in each group). Block randomization was used in this study. During the data collection phase, the purpose of the study will be explained to the parents of preterm infants by the researcher, and written consent will be obtained from the parents who agree to participate in the study through the "Informed Consent Form". Introductory Information Form, Physiological Parameter and rSO2 Follow-up Chart and Neonatal Comfort Scale created by the researcher will be used.
Second sub purpose; to determine the effect of facilitated tucking position on the infant's cerebral oxygenation (rSO2), physiological parameters (heart peak beat, SpO2 and respiratory rate), pain and comfort / comfort levels during the heel stick procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Single (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 24 Weeks 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adjusted gestational age of 28-36(+6) weeks at time of registration
排除标准
- •Mechanical ventilation,
- •Major congenital abnormalities,
- •Surgical or severe medical morbidity (bronchopulmonary dysplasia, NEC, sepsis, or intraventricular bleeding)
- •The mother is under 18 years of age
- •The mother is not willing to do kangaroo care
结局指标
主要结局
The first sub-purpose Outcome: physiological parameters of the premature infant- SpO2 level
时间窗: Change from baseline and 70 min
Defines the change of SpO2 level.
The first sub-purpose Outcome: physiological parameters of the premature infant- heart rate (min).
时间窗: Change from baseline and 70 min
Defines the change of heart rate (min) level.Philips IntelliVue MP40 device was used to monitor respiratory rate. Philips IntelliVue MP40 device was used to monitor heart rate (min).
The first sub-purpose Outcome: rSO2 level
时间窗: Change from baseline and 70 min
Defines the change of rSO2 level. The NIRS monitor (COVIDEN Operations Manual INVOS® System, Model 5100C) was used to monitor rSO2 levels. The normal range of the rSO2 measured by the device was between 55% and 85%.
The first sub-purpose Outcome: Neonates COMFORTneo scale
时间窗: Change from baseline and 70 min
The COMFORTneo scale is a Likert-type scale consisting of seven parameters: alertness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tonus. The items are rated between 0 and 10, and the score that can be obtained from the scale ranges between 6 and 30. A score of 4-6 indicates moderate pain and distress and that of 7-10 indicates severe pain and distress.
The first sub-purpose Outcome: physiological parameters of the premature infant-respiratory rate (min)
时间窗: Change from baseline and 70 min
Defines the change of respiratory rate (min) level.
次要结局
- The second sub-purpose Outcome: physiological parameters of the premature infant- respiratory rate(Change from baseline and 70 min)
- The second sub-purpose Outcome: rSO2 level(Change from baseline and 70 min)
- The second sub-purpose Outcome: Premature Infant Pain Profile Scale-Revised (PIPP-R)(Change from baseline and 70 min)
- The second sub-purpose Outcome:Neonates The COMFORTneo Scale(Change from baseline and 70 min)
- The second sub-purpose Outcome: physiological parameters of the premature infant- heart rate (min)(Change from baseline and 70 min)
- The second sub-purpose Outcome: physiological parameters of the premature infant- oxygen saturation (%SpO2)(Change from baseline and 70 min)
研究者
Fatma Taş Arslan
Professor
Selcuk University