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临床试验/NCT06371443
NCT06371443已完成不适用

The Effects of Sucking and Swallowing Exercises on the Transition Process to Oral Feeding in Premature İnfants

Istanbul Medipol University Hospital2 个研究点 分布在 2 个国家目标入组 82 人开始时间: 2021年12月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
82
试验地点
2
主要终点
The early feeding skills assessment tool (EFS)

研究概览

简要总结

Underdeveloped oral structures of preterm infants cause feeding problems. Therefore, the development of sucking reflexes of premature babies should be supported.

This study aimed to investigate the effect of suck-swallow training on the transition to oral feeding in premature infants.

The study was conducted as a randomized controlled experimental trial in the NICU of a public hospital in Istanbul. The study sample consisted of 82 premature infants. Of these infants, 41 were assigned to the experimental group and 41 to the control group. Study data were collected using the investigator-developed Premature Infant Data Collection Form and Early Feeding Skills Assessment Tool. Throughout the study, preterm infants in the experimental group (n=41) were given suck-swallow exercises for 12 minutes once a day before feeding for 14 days. SPSS21 was used to analyze the data.

详细描述

This study was conducted as a randomized controlled experimental study to evaluate the effect of sucking and swallowing training on the transition to oral feeding in premature infants. The study sought to answer the question, "Do suckling and swallowing exercises have an effect on the transition to oral feeding?". The study was carried out between December 2021 and June 2022 at the neonatal intensive care unit of a public hospital in Istanbul. The study sample consisted of infants who were admitted to the neonatal intensive care unit of a public hospital in Istanbul, who met the inclusion criteria, and whose parents consented to the study. A power analysis was performed to determine the number of subjects to be included in the study. The power of the test was calculated using the G*Power 3.1 program. Infants enrolled in the study were randomized in order of arrival to avoid bias. The randomization table was generated by "https://www.calculatorsoup.com" as follows.

Data were collected using the Premature Infant Data Collection Form and the Early Feeding Skills Assessment Tool.

The premature infant data collection form developed by the investigators consists of 2 parts. The first part contains descriptive information about the parents (gender, age, education level, number of children, social security). The second part contains descriptive details of the infant (sex, mode of delivery, Apgar score, week of birth, postmenstrual week at enrollment, birth weight, weight at enrollment, head circumference-height at birth, phototherapy status within the last 24 hours, oxygen support status).

Application in the experimental group: Informed consent was obtained from the parents of the infants in the experimental group who had low suckling success and met the inclusion criteria. After completing the premature infant data collection form, the investigator assessed the infant's sucking activity. Infants with no suck reflex were included in the study group. The oral motor stimulation exercises developed by Fucile and applied to the infants in the experimental group who needed suckling and swallowing exercises were evaluated according to the Early Feeding Skills measurement tool. The investigator performed the exercises on the infants once a day for 12 minutes before feeding for 14 days. After 14 days, the infants were assessed again using the EFS scale.

Application in the control group: First, informed consent was obtained from the parents of the infants in the control group who met the inclusion criteria. After completing the premature infant data collection form, the infant's sucking activity was assessed. Infants who did not show a suck reflex were included in the study group, and the infants were evaluated using the Early Feeding Skills (EFS) measurement tool at baseline and at 14 days.

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
None

入排标准

年龄范围
34 Weeks 至 37 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Premature babies with an updated gestational week of 34 weeks
  • Premature babies born at 34-37 weeks of gestation
  • Premature babies with stable vital signs
  • Premature babies with underdeveloped sucking activity

排除标准

  • intubated babies
  • Babies with multiple anomalies
  • Babies with asphyxia
  • Infants with unstable vital signs

结局指标

主要结局

The early feeding skills assessment tool (EFS)

时间窗: December 2021 and June 2022

This scale is a reliable tool that assesses skills that contribute to safe and successful oral feeding of preterm infants in 5 sub-dimensions. Sub-dimensions include respiratory regulation, oral motor function, swallowing coordination, feeding participation, and physiological stability.

次要结局

未报告次要终点

研究者

发起方
Istanbul Medipol University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

aysel kokcudogan

Principal investigator

Istanbul Medipol University Hospital

研究点 (2)

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