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临床试验/NCT05815706
NCT05815706已完成不适用

The Effect of the Supplemental Nursing System-Based Feeding on Time to Transition to Exclusive Breastfeeding, Sucking Success, and Discharge Time: A Randomized Controlled Trial on Preterm Infants

Istanbul Medeniyet University2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2018年11月20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
72
试验地点
2
主要终点
The time to transition to oral feeding (hours)

研究概览

简要总结

This study investigated the effect of the Supplemental Nursing System (SNS)-based feeding on the time to transition to exclusive breastfeeding, sucking success, and the time to discharge in preterm infants

详细描述

Nutrition is a critical problem in preterm infants. They should initially be enterally fed because they have poor sucking-swallowing-breathing coordination. Once a preterm infant develops that coordination, enteral feeding should be discontinued immediately. Then, the preterm should switch to oral feeding (breastmilk). However, preterm infants are not good at sucking because they get tired too quickly, have poor sucking skills, and lack enough experience. Therefore, we must use alternative supplemental feeding methods (bottle, spoon, dropper, cup, breastfeeding support system, and finger feeding) until preterm infants mature enough to meet their daily nutritional needs by breastfeeding alone (exclusive breastfeeding).

The Supplemental Nursing System (SNS) is an alternative supplemental feeding method that supports the development of sucking skills while providing the preterm infant's nutritional needs. This study investigated the effect of the Supplemental Nursing System (SNS)-based feeding on the time to transition to exclusive breastfeeding, sucking success, and the time to discharge in preterm infants.

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)

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

  • being between the gestational ages of 30 to 34 weeks
  • having a birthweight of ≥1000 g
  • having an APGAR score of >6
  • having stabilized for 48 hours after receiving mechanical ventilator or continuous positive air pressure or both
  • being exclusively gavage-fed with breast and/or formula and ready to switch to oral feeding
  • being willing to breastfeed

排除标准

  • having a congenital malformation that may cause asphyxia and affect breathing
  • having an intraventricular hemorrhage, intracranial hemorrhage, or periventricular leukomalacia
  • having intestinal anomalies or hyperbilirubinemia requiring exchange transfusion
  • having respiratory distress syndrome, bronchopulmonary dysplasia, or other chronic lung diseases.

结局指标

主要结局

The time to transition to oral feeding (hours)

时间窗: up to three weeks

It was measured when the preterm infant swiched from gavage feeding to oral feeding.

Time to discharge (hours)

时间窗: up to 2 months

It was measured at discharge

The sucking success (First measurement)

时间窗: at the beginning of the study, up to three weeks

The sucking success was assessed using the LATCH Breastfeeding Assessment Tool. The tool was developed by Jensen et al. (1994) and adapted to Turkish by Yenal and Okumus (2003). It consists of five evaluation criteria: L (Latch on breast), how well the infant latches onto the breast; A (Audible swallowing), the amount of audible swallowing noted; T (Type of nipple), the mother's nipple type; C (Comfort, breast/nipple), the mother's level of comfort in relation to the nipple; and H (Hold/Help), the amount of help the mother needs to hold her infant to the breast. Each item is rated on a scale of 0 to 2. The total score ranges from 0 to 10, with high scores indicating successful sucking.

The time to transition to exclusive breastfeeding (hours)

时间窗: up to two weeks

It was measured when the preterm infant transitioned to exclusive breastfeeding

The sucking success (Last measurement)

时间窗: through study completion, an average of 2 months

The sucking success was assessed using the LATCH Breastfeeding Assessment Tool. The tool was developed by Jensen et al. (1994) and adapted to Turkish by Yenal and Okumus (2003). It consists of five evaluation criteria: L (Latch on breast), how well the infant latches onto the breast; A (Audible swallowing), the amount of audible swallowing noted; T (Type of nipple), the mother's nipple type; C (Comfort, breast/nipple), the mother's level of comfort in relation to the nipple; and H (Hold/Help), the amount of help the mother needs to hold her infant to the breast. Each item is rated on a scale of 0 to 2. The total score ranges from 0 to 10, with high scores indicating successful sucking.

The sucking success (Second measurement)

时间窗: 48 hours after the second measurement of sucking success

The sucking success was assessed using the LATCH Breastfeeding Assessment Tool. The tool was developed by Jensen et al. (1994) and adapted to Turkish by Yenal and Okumus (2003). It consists of five evaluation criteria: L (Latch on breast), how well the infant latches onto the breast; A (Audible swallowing), the amount of audible swallowing noted; T (Type of nipple), the mother's nipple type; C (Comfort, breast/nipple), the mother's level of comfort in relation to the nipple; and H (Hold/Help), the amount of help the mother needs to hold her infant to the breast. Each item is rated on a scale of 0 to 2. The total score ranges from 0 to 10, with high scores indicating successful sucking.

次要结局

未报告次要终点

研究者

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

Aynur Aytekin Ozdemir

Professor

Istanbul Medeniyet University

研究点 (2)

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