The Effect of the Tactile/kinesthetic Stimulus Program on the Maturation of Sucking Ability in Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- transition time (day) to full oral feeding
研究概览
简要总结
The study will be carried out as a prospective randomized controlled clinical study to determine the effect of tactile/kinesthetic stimulus program on preterm infants on transition time to full sucking, sucking success and hospital stay.
详细描述
Application of the Research Tactile/kinesthetic Group After the stability in the general health status of the babies and the oral feeding decision are made, for 14 days, 2 times a day, just before feeding; There will be a 15-minute tactile/kinesthetic application. Complications that may develop during the tactile/kinesthetic application in infants will be monitored by evaluating the physical findings of the preterm infant and on the bedside monitor. In cases such as decreased oxygen saturation, apnea and bradycardia during the tactile/kinesthetic intervention, the procedure will not be performed or will be delayed until the baby regains stability.
Note: The application will be carried out by showing the necessary sensitivity for the preterm baby (not shaking the baby, not moving the baby suddenly, the temperature of the hands being close to the baby's body temperature, etc.) and by the researcher nurses experienced in NICU.
Control Group Tactile/kinesthetic applications will not be applied to the control group and these babies will be followed up for 14 days and at discharge after the stability of the general health status of the babies is ensured and the oral feeding decision is made.
In both groups; Baby scales and tape measure will be used for anthropometric measurement of body weight before and after breastfeeding. Other data will be obtained from the patient file and observations made during the hospitalization of the preterm infant.
The LATCH Breastfeeding Diagnosis Form (during the first mother's breastfeeding) will be filled in by observation, by the researcher and an observer nurse, as it is an observation-based form. The researcher will train the observer on the use of the LATCH Breastfeeding Diagnostic Form. The researcher and observer will simultaneously and independently evaluate each preterm infant by scoring the LATCH Breastfeeding Diagnostic Form during the breastfeeding period. In order to evaluate the agreement among the observers, the agreement will be evaluated by looking at Cohen's Kappa coefficient. The LATCH second measurement will be made on Day 5.
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
The volunteer (newborn's mother or father) will not know which group she/he will be in before joining the study. After accepting to the participate in the study, the volunteer will be informed abouth which group her/his newborn will be in.
入排标准
- 年龄范围
- 28 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Born between 28-32 weeks of gestation,
- •Stable vital signs,
- •1st and 5th minute APGAR score between 6-10,
- •Babies who have received mechanical ventilator or continuous positive air pressure (CPAP) or both support after 48 hours have passed after stabilization,
- •Does not have an anomaly that will prevent feeding,
- •Oral feeding decision has been made,
- •Babies of mothers who are willing to breastfeed their babies,
- •Babies of parents who volunteered to participate in the study will be taken.
排除标准
- •Infants with severe asphyxia,
- •Babies born with low birth weight according to their gestational week,
- •Having an anomaly that will prevent her from feeding,
- •Babies with unstable vital signs,
- •Babies with congenital anomalies or serious complications
- •Infants with intraventricular bleeding.
- •Dismissal Criteria
- •Babies whose oral feeding process is interrupted for more than 1 day due to neonatal problems.
结局指标
主要结局
transition time (day) to full oral feeding
时间窗: within the first 30 days of birth
This is the data on which day full oral feeding is started after admission to the neonatal intensive care unit.
time (day) to first breastfeeding
时间窗: within the first 30 days of birth
This is the data on which day breastfeeding feeding is started after admission to the neonatal intensive care unit.
change in weight before and after feeding
时间窗: the date of at discharge (up to 40 weeks)
babies will be weighed before and after feeding on the first, fifth, ninth, thirteenth day and at discharge
transition time(day) to oral feeding trials
时间窗: within the first 30 days of birth
This is the data on which day oral feeding trials were performed after admission to the neonatal intensive care unit. intensive care unit.
transition time (day) to full enteral feeding
时间窗: within the first 30 days of birth
This is the data on which day full enteral feeding is started after admission to the neonatal intensive care unit.
transition time (day) to enteral feeding trials
时间窗: within the first 30 days of birth
This is the data on which day full enteral feeding is started after admission to the neonatal intensive care unit.
latch score (first day of breastfeeding)
时间窗: first breastfeeding process (20 minutes)
Using LATCH Scale. The minimum LATCH score is 0 and the maximum is 10.
length of hospital stay (days)
时间窗: the date of at discharge (up to 40 weeks)
length of hospital stay (days)
latch score (fifth day of breastfeeding)
时间窗: fifth day breastfeeding process (20 minutes)
Using LATCH Scale. The minimum LATCH score is 0 and the maximum is 10.
次要结局
未报告次要终点
研究者
Gonca Karatas Baran
Dr Nurse
Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital