Effects of Kangaroo Care on Circadian Rhythm, Growth and Physiological Effects of Newborns Effect of Parameters on Breast Milk Cortisol Levels: Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Newborn Circadian Rhythm Tracking Chart
研究概览
简要总结
This study was planned to investigate the effect of premature babies receiving regular kangaroo care in the NICU on circadian rhythm, growth and physiological parameters, and breast milk cortisol levels
详细描述
Kangaroo Care (KC) may have positive effects on biological phase markers of immature circadian rhythms in newborns. KC provides circadian rhythm development by reducing the stress of newborns. Skin-to- skin contact intervention, which is similar to kangaroo care, affects the ẞ-endorphin concentration, which reduces pain in premature babies, and is known to reduce cortisol levels. KC, which supports exclusive breastfeeding and breastfeeding, can affect the circadian rhythm in newborns by providing information about the time of day to newborns through the increase in breastfeeding rates and the hormones and immune elements contained in breast milk. Although there are a limited number of studies in the literature examining the circadian rhythm or sleep-wake cycle of babies in the neonatal intensive care unit, no study has been found examining the circadian rhythm of babies receiving regular kangaroo care using brain imaging methods. In this respect, the study has unique value. In addition, within the scope of the study, regular kangaroo care for three days had a positive effect on the growth and physiological parameters of babies any studies examining the effect of breast milk on cortisol levels No study was found.
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 (Investigator)
盲法说明
The sample size of the study was calculated using the G power program. In the power analysis performed with the t test, one-way hypothesis, 0.80 effect size, 90% power, 0.05 significance level, assignment rate: 1, it was determined that a total of 56 preterm babies (Experiment: 28, Control: 28) would provide sufficient sample size.
入排标准
- 年龄范围
- 28 Weeks 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being between 28+0-37 weeks of pregnancy,
- •Birth weight >1000 g,
- •APGAR score >7 at the 5th minute after birth,
- •Ability to feed every 2-3 hours
排除标准
- •Getting mechanical ventilation support
- •Undergoing surgery
- •Having diseases and disorders such as congenital brain malformations, meningitis, seizures, encephalopathy, congenital abnormalities, history of intraventricular bleeding, herpes, sepsis and heart or metabolic diseases.
- •Taking medication that affects sleep patterns, such as theophylline, phenobarbital, midazolam, caffeine, fentalnil
- •Having developed intraventricular hemorrhage
结局指标
主要结局
Newborn Circadian Rhythm Tracking Chart
时间窗: First Day, (10:00-12:00 AM) - First Night (22:00- 24:00 PM)
To measure circadian rhythms, BIS spectrometry will be attached to the baby's forehead area, as specified in the user manual, after the babies in the experimental and control groups are given group care in the morning and evening The device provides a different application to babies as it records the duration of being in "awake, REM, N-REM/ STAGE I, N-REM/ STAGE II, N-REM/ STAGE III, N-REM/ STAGE IV" measured in 5-minute periods. It will not be done. The sensor will be removed from the baby's forehead at the next care hour. At the end of 3 days, records will be taken from the BIS monitor and recorded in the "Newborn Circadian Rhythm Tracking Chart
Breast milk cortisol levels Tracking Chart
时间窗: First Day (12:00AM) - first Night (24:00 PM)
To measure breast milk cortisol levels, breast milk samples will be collected by the researcher by expressing breast milk at 12.00 on the 1st, 2nd and 3rd days of the experimental and control groups. This period was determined by considering the possibility of terminating kangaroo care in the experimental group as it coincided with the babies' care and feeding hours at 12:00, and the times when the mother would want to receive kangaroo care for more than 70 minutes, and the maximum kangaroo care would last 120 minutes
Growth Tracking Chart
时间窗: First Day (10:00 AM)
The chart was created by the researcher in such a way that body weight (g) from growth parameters would be recorded daily for 3 days.
Physiological Parameter Follow-up Form- body temperature (°C)
时间窗: First Day (10:00 AM) and First Night (22:00 PM)
Body temperature (°C) found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the first day.
Physiological Parameter Follow-up Form-oxygen saturation (mmHg)
时间窗: First Day (10:00 AM) and First Night (22:00 PM)
Oxygen saturation found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the first day.
Physiological Parameter Follow-up Form-heart rate (min)
时间窗: First Day (10:00AM) and First Night (22:00 PM)
Heart rate found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the first day.
Physiological Parameter Follow-up Form-respiratory rate (min)
时间窗: First Day (10:00 AM) and First Night (22:00 PM)
Respiratory rate found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the first day.
次要结局
- Newborn Circadian Rhythm Tracking Chart(Third Day (10:00-12:00 AM) - Third Night (22:00-24:00 PM))
- Breast milk cortisol levels Tracking Chart(Third Day (12:00 AM) - Third Night (24:00 PM))
- Growth Tracking Chart(Third Day (10:00 AM))
- Physiological Parameter Follow-up Form- body temperature (°C)(Third Day (10:00 AM) - Third Night (22:00 PM))
- Physiological Parameter Follow-up Form-oxygen saturation (mmHg)(Third Day (10:00 AM) - Third Night (22:00 PM))
- Physiological Parameter Follow-up Form-heart rate (min)(Third Day (10:00 AM) - Third Night (22:00 PM))
- Physiological Parameter Follow-up Form-respiratory rate (min)(Third Day (10:00 AM) - Third Night (22:00 PM))
研究者
Sibel Küçükoğlu
Responsible researcher (Prof)
Selcuk University