Effect of Chronobıologıcal Approach Feedıng Model on Cırcadıan Rhythm, Growth and Physıologıcal Parameters in Newborn: A Randomızed Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Newborn Circadian Rhythm Follow-up Chart
研究概览
简要总结
This study was planned to evaluate the effect of "feeding model with chronobiologic approach" on circadian rhythm, growth and physiologic parameters of newborns.
详细描述
The newborn period is a period when all babies need their basic needs to be met and all babies are very sensitive physiologically, neuro-biologically and psycho-emotionally, but the newborn period is also a very important period in the development of circadian rhythm. It is important to establish a healthy sleep pattern for the formation of the circadian rhythm and the continuation of the functions of all other systems, especially the central nervous system. Formation of circadian rhythm in newborns; It shows a better development in the first 3 months with the effect of environmental factors such as nutrition, light, mother-baby interaction. Breast milk is a nutrient for the growth and development of babies, in addition, breast milk plays an active role in the formation of the baby's circadian rhythm by transmitting information about the time of day to the babies through components such as hormones and immune elements. In cases where breastfeeding is not possible, it is thought that the delivery of expressed breast milk to the babies simultaneously with the "feeding model with a chronobiological approach" has important effects on the sleep-wake cycle and growth and development. In studies examining circadian rhythm in newborns in the world and in our country, the limited number of studies evaluating the relationship between circadian rhythm and breast milk draws attention and further studies are recommended. However, there is no published study evaluating the effect of simultaneous administration of breast milk to the infant in line with the "feeding model with chronobiologic approach" on circadian rhythm, growth and physiologic parameters of newborns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 28 Weeks 至 42 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age between 28-42 weeks
- •Birth weight between 1500 and 4200 gr
- •Hospitalization for at least 3 days
- •Exclusive breastfeeding (oral/ enteral)
- •Feeding at 3-hour intervals
- •Stable health condition
- •Spontaneous breathing
排除标准
- •Babies fed outside of 3-hour intervals (hourly or two-hourly intervals)
- •5th minute apgar score below 4 at the time of delivery
- •Resuscitation requirement
- •Having a congenital anomaly
- •Interventional intervention in the head region
- •Central nervous system dysfunction
- •Postpartum medical complications
结局指标
主要结局
Newborn Circadian Rhythm Follow-up Chart
时间窗: First measurement -up the end of the first day circadian rhythm measurements
At the end of 3 days, the records of the duration of the babies' being in "Wakefulness, REM, N-REM / EVRE I, N-REM / EVRE II, N-REM / EVRE III, N-REM / EVRE III, N-REM / EVRE IV" measured by Bispectral Index (BIS) in 5-minute periods within a 24-hour time cycle will be taken from the BIS monitor records and entered into the "Newborn Circadian Rhythm Follow-up Chart" created by the researcher.
Newborn Introductory Information Form
时间窗: First measurement - Before the study (before randomization)
The form prepared by the researcher in line with the literature (Galland et al., 2012; Huang et al., 2021; Caba-Flores et al., 2022) consists of questions including the obstetric characteristics of the infant such as gender, gestational-postnatal age, type of delivery, APGAR scores, birth weight, height, head circumference, and the current clinical status of the infant such as diet, comorbidity, and total number of hospitalization days. The questionnaire form was sent to 5 academicians specialized in Pediatric Nursing, their expert opinions were obtained, and the questionnaire form was finalized by making the necessary changes in line with their suggestions. Information about the newborns in the control and experimental groups was collected by the researcher through the "Newborn Introductory Information Form" before the study, hospital records of the newborn and the primary nurse through face-to-face interview method will be collected in about 5 minutes.
Newborn Growth and Physiologic Parameters Follow-up Chart
时间窗: First measurement - up the end of the first day night and day measurements
"Temperature (°C), Pulse Rate (min), Blood Pressure (mmHg), Respiratory Rate (min), O2 Saturation (mmHg) will be recorded for 3 days during the day-night cycle of the infants followed in both groups. Physiologic parameters will be measured 1 hour after the 2nd daytime feeding and 1 hour after the 2nd nighttime feeding (i.e. after the baby's 6th feeding). The amount of breast milk received by the infant (ml)" will be monitored for three days separately in the daytime (06:00-17:59) and nighttime (18:00-05:59) cycle. In addition, the infants will be followed up in terms of "Body Weight (g), Height (cm), Head circumference (cm), Persentile" values until the infants are discharged from the hospital and all these parameters will be recorded through the "Newborn Growth and Physiological Parameters Follow-up Chart" created by the researcher.
次要结局
- Newborn Circadian Rhythm Follow-up Chart(Third measurement - up the end of the third day circadian rhythm measurements)
- Newborn Growth and Physiologic Parameters Follow-up Chart(Third measurement - up the end of the third day night and day measurements)
研究者
Sibel Küçükoğlu
Professor
Selcuk University