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临床试验/NCT05683210
NCT05683210已完成不适用

Comparison of The Effects of Initial Oral Feeding by Cup and Bottle-Feeding on Physiological Characteristics and Feeding Performance of Preterm Intants

Istanbul University - Cerrahpasa (IUC)1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年1月13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
80
试验地点
1
主要终点
Feeding Status

研究概览

简要总结

The research was planned in a randomized controlled experimental design to determine the effects of the cup and bottle used during the first oral feeding on physiological characteristics and feeding performance in preterm infants. The research was carried out between January 2021 and February 2022 at the Neonatal Intensive Care Unit of Göztepe Süleyman Yalçın City Hospital. Research data were obtained from preterm infants who were born before 34 weeks of gestation, appropriate to selection of study group criterias and hospitalized in the neonatal intensive care unit. A total of 80 babies in the sample group were randomly assigned to the experimental (bottle) and control (cup) groups. Oxygen saturation, heart rate, feeding performance and test weight before, during and after feeding of preterms in both groups were compared. There was no statistically significantly difference between the experimental and control groups in terms of oxygen saturation and heart rate.

详细描述

The coordination of sucking, swallowing and breathing is necessary for the preterm infant to be effectively and safely fed by the oral route. Although the sucking motion begins in the 27-28th week, the coordination of sucking, swallowing, and breathing appears in the 32-34th week. Introducing oral feeding to preterm infants is recommended by sucking the mother's breast when they are ready for oral feeding. Preterm infants are fed through complementary feeding methods such as a bottle, spoon, dropper, cup, and finger feeding until they reach the condition to meet their nutritional needs by sucking the mother's breast.

Bottle feeding is one of the nutritive sucking methods commonly used in both preterm and term infants worldwide. When the mother is unable to breastfeed or breast milk is not available, preterm infants can be fed with a bottle. Bottle feeding contributes to effective feeding and helps the infant to relax by meeting the sucking reflex. Cup feeding has been used in developed and developing countries for many years to feed premature infants and those with low birth weights. Cup feeding is a simple, practical, effective, and low cost method that can be used in infants who can swallow but are unable to suck well enough to be fed completely from the mother's breast, and in cases where an alternative such as a gastric catheter or a bottle is required for feeding.

Studies that compared bottle and cup feeding reported that the swallowing performance of preterm infants fed with a bottle was better, the length of hospital stay was longer in preterm infants fed with a cup, and the duration of feeding was longer in preterms fed with a cup compared to those fed with a bottle, the rate of breastfeeding after discharge was higher in those fed with a cup, no significant difference was found in weight gain, but the quantity of food intake was less and the rate of food spillage was higher in preterm infants fed with a cup compared to those fed with a bottle. For all of these reasons, bottle feeding is reported to be a safer and more appropriate method.

This randomised controlled experimental study was carried out to compare the effect of cup and bottle feeding on physiological characteristics and feeding performance in preterm infants born at or below the 34th gestational week. A power analysis was used to determine. The study included a total of 80 preterms, 40 preterms for each group. The parents of preterm infants who met the inclusion criteria granted their written and verbal consent.

Experimental 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 (Participant)

入排标准

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

入选标准

  • Criteria for Sample Selection
  • Being at the ≤34th gestational week according to the last menstrual period of the mother of the preterm
  • Being at the ≥30th postmenstrual week on the date of inclusion in the study
  • Having a body weight of 1000 grams or more on the date of inclusion in the study
  • Switching from enteral feeding to oral feeding for the first time with the joint decision of the physician and nurse
  • Breastfeeding
  • Showing physiological and behavioural signs indicating that the infant is ready for oral feeding (tolerating full enteral feeding, exhibiting sucking behaviour, opening the mouth by responding to stimuli around the mouth, normal physiological values [HR of 120-160/min, SpO2≥90], maintaining alertness, keeping the body in flexion posture)
  • Having parental consent for inclusion in the study and an informed consent form signed by parents

排除标准

  • Having diagnostic criteria for severe bronchopulmonary dysplasia (≥30% O2 requirement and/or positive pressure requirement at the 36th postmenstrual week or at discharge in preterm infants with a gestational age of <32 weeks; ≥30% O2 requirement or positive pressure requirement at the 56th postnatal day or at discharge in preterm infants with a gestational age of ≥32 weeks)
  • Having an anomaly such as cleft palate, cleft lip
  • Having gastrointestinal, neurological or genetic disease (NEC, IVH, hydrocephalus, asphyxia, Down syndrome, short bowel syndrome, etc.)

结局指标

主要结局

Feeding Status

时间窗: maximum 30 minutes

In order to assess the feeding status of the infant, his/her time of feeding and the amount of nutrient he/she receives in a minute will be calculated. In order to determine his/her time of feeding, a phone chronometer will be started as soon as he/she begins feeding and it will be stopped when feeding is over. All infants in experimantal group and control group will be fed with a slow-flow bottle branded Avent which is designed for premature infants. It will be calculated how much (cc) of the total amount of nutrient ordered by the doctor the infant receives. The total amount of nutrient received by the infant will be divided into the time of feeding and thus the amount of nutrient received in a minute (cc) will be calculated.

次要结局

  • Heart Rate(All babies in experimental group and control group will be recorded in the registration form by the observing nurse once half an hour before the feeding time, 30 minutes before the feeding time, during the feeding and at 30 minutes after the feeding.)
  • Oxygen Saturation(All babies in experimental group and control group will be recorded in the registration form by the observing nurse once half an hour before the feeding time, 30 minutes before the feeding time, during the feeding and at 30 minutes after the feeding.)

研究者

发起方
Istanbul University - Cerrahpasa (IUC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sukran Musaoglu

Nurse

Istanbul University - Cerrahpasa (IUC)

研究点 (1)

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