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临床试验/NCT06259604
NCT06259604尚未招募不适用

The Effect of Oral Motor Intervention (PIOMI) and Combined Kangaroo Care Applied to Preterm Babies on Weight Gain, Oral Feeding Skills, Transition to Full Oral Feeding and Discharge Time: Randomized Controlled Study

Suleyman Demirel University2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
102
试验地点
2
主要终点
Transition time to full oral feeding

研究概览

简要总结

The purpose of this research; The aim of this study is to examine the effects of oral motor intervention (PIOMI) and combined kangaroo care applied to preterm babies on weight gain, oral feeding skills, transition to full oral feeding and discharge time.

详细描述

The most important responsibility for the transition to oral feeding in the early period falls on neonatal intensive care nurses. Neonatal intensive care nurses should evaluate premature babies' readiness for feeding and use evidence-based practices in this regard. Studies show that there are different applications (piomi, fucile, etc.) in oral motor stimulation that provides a single sensory input. One of the most commonly used applications is the PIOMI (Preterm Infant Oral Motor Intervention) application developed by Lessen et al. (2011). PIOMI has been shown to shorten the duration of transition to oral feeding and hospital stay, helps in weight gain, increases sucking capacity and transition from breast to breastfeeding. It is stated that it accelerates the duration. However, PIOMI; such as massage therapy, breastfeeding, oral support and non-nutritive sucking, music therapy. A limited number of studies show that combined use is more effective, and more research is needed in this area.

One of the methods that accelerates the transition to oral feeding in preterm babies and is effective in physiological stability and neuromotor development is kangaroo mother care. No research has been found in the literature examining the effect of kangaroo care and PIOMI application on the oral feeding process of preterm babies when applied in combination. Additionally, no study has been found that evaluated the maturity of oral feeding skills and early feeding skills in which PIOMI and kangaroo care were combined. In this context, research; It will be carried out to examine the effects of oral motor intervention (PIOMI) and combined kangaroo care applied to preterm babies on weight gain, oral feeding skills, transition to full oral feeding and discharge time.

The research is a randomized controlled trial. The research will be carried out in the Neonatal Intensive Care Unit of Isparta City Hospital between March 2024 and March 2025. Neonatal Intensive Care Unit consists of Level 3 with 12 beds, Level 2 with 8 beds, mother-baby adaptation room with 10 beds, 3 isolation rooms and 1 breastfeeding room. There is a breastfeeding nurse at the clinic during the day (8-16) and provides breastfeeding education to mothers. At other times (16-08), each nurse provides breastfeeding counseling to the parents of the baby for whom she/he is responsible for care. Mothers express their milk in the breastfeeding room and hand it over to the nurses, writing the name, date and time on it. Receiving the milked milk to the clinic, storing it and preparing it by heating it. It is carried out in accordance with the Ministry of Health and Food and Drug Administration (FDA). This milk is monitored by each patient's own nurse, and excess milk is put in the freezer. The milk to be used is placed in the milk cabinets in the rooms, and the milk is withdrawn day and night by the nurses according to the doctor's request, before feeding, in accordance with the time, and is heated using the bain-marie method and given to the babies. There is no written protocol in the clinic regarding the transition and maintenance of oral feeding of newborns. Oral feeding is initiated by the joint decision of the neonatal physician and neonatal nurse, taking into account the postmenstrual week, physiological parameters and individual conditions of the newborns. In oral feeding of preterm babies, syringes are generally used and babies are fed in a semi-elevated position.

The data of the research will be collected with the "Informed Volunteer Consent Form", "Baby Introduction Form", "Early Feeding Skills Assessment Tool" and "Nutrition Tracking Chart".

There are three groups in the research: PIOMI, PIOMI+kangaroo care and control group.

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

One-sided blinding method will be applied in the research. Only one of the researchers has a PIOMI practitioner certificate and interventions will be carried out only by this researcher. The PIOMI practitioner researcher will perform all interventions of PIOMI and combined methods himself and will not tell other researchers which group the babies are in. All measurements of the babies, except PIOMI, will be carried out by a single researcher in the research group.

入排标准

年龄范围
29 Weeks 至 32 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Gestational age at birth is 28-32 weeks, depending on the mother's last menstrual period,
  • can be administered PIOMI per week and can tolerate the transition to oral feeding,
  • Able to tolerate the transition to oral feeding according to the cue-based feeding model,
  • Maintains physiological stabilization (heart rate, oxygen saturation, respiratory rate) during the procedure when oxygen support is provided with room air or nasal cannula or hood.
  • Apgar score of 4 or higher at the 5th minute after birth
  • Not receiving mechanical ventilator support or 48 hours after weaning from mechanical ventilator support
  • Babies with written and verbal permission from their parents will be included in the research.

排除标准

  • Those with congenital anomalies (cleft lip, cleft palate, gastroschisis, omphalocele, short bowel syndrome and other anomalies) According to the criteria of Jobe and Bancalari (2001), patients with severe bronchopulmonary dysplasia and patent ductus arteriosus (PDA) requiring surgical treatment Babies with gastrointestinal, neurological and genetic diseases (necrotizing enterocolitis, level 3 and 4 intracranial hemorrhage, periventricular 25 leukomalacia, hydrocephalus, down syndrome) will not be included in the study.

结局指标

主要结局

Transition time to full oral feeding

时间窗: Up to 14 days

The baby's transition to full oral feeding will be recorded.

weight change

时间窗: Up to 14 days

The baby's weight chage will be recorded.

Early Feeding Skills Assessment Tool Scores

时间窗: Before the intervention and on the 14th day of the intervention. The overall Early Feeding Skills Assessment Tool score is the sum of the 5 subscale scores and ranges from 19 to 57. Higher scores indicate more mature feeding skills.

Oral motor control will be evaluated.

Discharge period

时间窗: through the baby's hospital admission to discharge

The time from hospital admission to discharge will be calculated.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Serife Tutar

Assistant professor

Suleyman Demirel University

研究点 (2)

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