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临床试验/NCT06194513
NCT06194513尚未招募不适用

Examining the Effect of Oral Motor Intervention Applied to Preterm Babies by Their Mothers at Different Frequencies on Oral Feeding Performance and Mother Baby Bonding

Marmara University2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年1月10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
42
试验地点
2
主要终点
The LATCH Breastfeeding Assessment Tool (Latch Audible Swallowing, Type of Nipple, Comfort of Breast/Nipple, H-Hold/ Position)

研究概览

简要总结

Babies who have been discharged from the neonatal intensive care unit and have difficulty in oral feeding will be identified. Oral Motor Intervention (PIOMI) will be taught to the mothers of these babies and asked to practice. As a result of this application, the change in oral feeding skills in babies and its effect on mother-infant bonding will be evaluated.

详细描述

The aim of this study is to observe the changes in babies' oral feeding skills and mothers' mother-baby attachment evaluation status as a result of oral motor intervention (PIOMI) applied to preterms with oral feeding difficulties.

An estimated 20 million babies are born preterm (before the 37th week of gestation) each year in the world, and this number is increasing, and complications of prematurity are among the leading causes of death among children under 5 years of age. Three-quarters of these deaths are preventable with current, cost-effective interventions.

Problems experienced after discharge include delayed feeding ability, food rejection, difficulty in transitioning to solid foods, and slowdown in growth. The reasons that lead to these difficulties are; These are post-discharge health problems such as immaturity, parenteral or tube feeding as opposed to oral motor experience, and neurological or cognitive disorders. All of these make it difficult for the child to develop nutritional skills and cause stress, depression, and self-confidence in the family.

Premature Infant Oral Motor Intervention (PIOMI) is a five-minute, eight-step oral motor intervention applied to preterm infants that aims to mimic the in utero oral experience that strengthens and improves feeding mechanisms. PIOMI provides assisted movement to activate muscle contraction for suckling and oral feeding, generating force to move against resistance, increasing functional response to pressure. It improves control of movements in accordance with a specific protocol that includes light contact with fingertips on the lips, cheeks, chin, gums, palate and tongue for the first three minutes, and pacifier/thumb sucking for the last two minutes. It was developed by Lessen BS to provide oral motor stimulation in preterm babies and its reliability study was conducted. The Turkish adaptation of the application was made by Selver Güler and Zerrin Çiğdem in 2021.

This oral motor intervention will be taught to the mother by a physiotherapist trained in this field, and it is planned that the mother will perform the application. In this way, premature babies with low immunity will not risk their health and will be given the opportunity to be treated more safely at home rather than in a hospital environment, which will save time and money. The effect of oral motor intervention frequency on oral motor skills will also be examined through applications at different frequencies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 90 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Participation in the study is accepted by the family
  • PIOMI can be applied and whose clinical condition is stable,
  • Born earlier than 37 weeks,
  • Those who have not been diagnosed with any disorder in swallowing functions,
  • Without congenital anomalies and systemic diseases,
  • Vital signs are stable,
  • Babies without congenital anomalies or serious complications

排除标准

  • Participation in the study is not accepted by their family,
  • Those with congenital anomalies and systemic diseases.
  • Those who have been diagnosed with swallowing disorder,
  • Those with congenital disorders or birth trauma,
  • Diagnosed with severe asphyxia,
  • Those with intraventricular bleeding,
  • Those with Neonatal Abstinence Syndrome,
  • Those with Fetal Alcohol Syndrome,
  • Babies connected to a ventilator

结局指标

主要结局

The LATCH Breastfeeding Assessment Tool (Latch Audible Swallowing, Type of Nipple, Comfort of Breast/Nipple, H-Hold/ Position)

时间窗: 0, 7. day, 14. day

LATCH is a tool created by analogy with the Apgar score system in terms of scoring method, and its evaluation is quick and easy. The Turkish validity of the Assessment Tool was conducted by Demirhan in 1997, Koyun in 2001, and Yenal and Okumuş in 2003, and it was recommended to be used as a reliable tool. The highest score that can be obtained from the scale is 10 and the lowest score is 0. Increasing scores from the scale indicate breastfeeding success. Cronbach Alpha value of the LATCH Breastfeeding Assessment Tool; Yenal and Okumuş found it as 0.95, Demirhan as 0.94, and Koyun as 0.96. The scale considers mother and baby together. It can be evaluated by a healthcare professional or the mother. In the evaluation; It includes the criteria for breast retention, the baby's swallowing movement, the type of nipple, the mother's comfort with the breast and nipple, and the position of holding the baby.

Preterm Infant Oral Feeding Readiness Assessment (PIOFRA/ POFRAS)

时间窗: 0, 7. day, 14. day

This scale consists of 5 categories (corrected gestational age, behavioral organization, mouth posture, oral reflexes, non-nutritive sucking) and 18 items and evaluates readiness for oral feeding in preterm infants. The scale is scored between 0-2 and the maximum score is 36. The cut-off point for switching a preterm baby to oral feeding was determined as 30 . Turkish Validity-Reliability: In the Turkish adaptation of this scale made by Çamur and Çetinkaya in 2020, the cut-off point was found to be 29.

次要结局

  • The Mother to Infant Bonding Scale (MIBS)(0, 7. day, 14. day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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