跳至主要内容
临床试验/NCT05802095
NCT05802095已完成不适用

The Effect of Supplemental Feeding Tube Devices Used in Preterms on Baby's Breastfeeding Success and Mother's Breastfeeding Self-Efficacy

Medipol University2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2023年5月2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
60
试验地点
2
主要终点
LATCH a breastfeeding charting system and documentation tool

研究概览

简要总结

The research will be carried out as a randomized controlled experimental design to evaluate the effectiveness of the breastfeeding support system to increase sucking success in premature infants receiving care in the NICU and breastfeeding self-efficacy in mothers.

In the study, the experimental and control groups will be determined by randomization of premature babies hospitalized in the NICU. While the babies in the control group will be fed with the routine feeding method (bottle) of the NICU, the babies in the experimental group will be fed with the breastfeeding support system by their mother. Research data will be collected using the Premature Baby and Its Mother Information Form, Premature Baby Follow-up Form, LATCH Breastfeeding Diagnostic Scale and Breastfeeding Self-Efficacy Scale-Short Form.

详细描述

Premature babies have to cope with many problems in the neonatal intensive care unit (NICU) in the postnatal period, and feeding problems are the leading of these problems. Oral feeding of premature infants is a complex and dynamic process consisting of the interaction of oral-motor, neurological, cardiorespiratory and gastrointestinal systems. Because they are anatomically and physiologically immature, they often cannot coordinate their sucking, swallowing and respiration for oral feeding, and they often have difficulty in oral feeding. Therefore, feeding premature babies in the NICU is provided by an orogastric or nasogastric tube. Continuing the feeding with the gavage method for a long time causes a delay in the acquisition of the motor skills required for oral feeding. Therefore, premature babies should be switched to oral feeding when they are physiologically ready. It is known that growth and developmental retardation are seen in premature babies if appropriate and adequate nutrition is not provided on time.

The most basic criterion sought in the transition to oral feeding in premature babies is the development of feeding skills. Different oral stimulus interventions have been developed to support and strengthen the development of oral-motor functions, create sufficient suction power, and start oral nutrition earlier. Tactile/kinesthetic stimulation, oral stimulation, swallowing exercises, non-nutritive sucking, gentle pressure on the cheeks, lips, chin and palate are among the most common sensorimotor interventions. It is reported that these interventions accelerate the transition time to oral feeding. Successful sucking transition from gavage to full oral feeding is one of the most important determinants of both discharges from the NICU and the growth and development of premature infants. This study will evaluate the effect of the breastfeeding support system used in premature babies on the baby's sucking success and the mother's breastfeeding self-efficacy.

The research will be carried out as a randomized controlled experimental design to evaluate the effectiveness of the breastfeeding support system to increase sucking success in premature infants receiving care in the NICU and breastfeeding self-efficacy in mothers.

In the study, the experimental and control groups will be determined by randomization of premature babies hospitalized in the NICU. While the babies in the control group will be fed with the routine feeding method (bottle) of the NICU, the babies in the experimental group will be fed with the breastfeeding support system by their mother. Research data will be collected using the Premature Baby and Its Mother Information Form, Premature Baby Follow-up Form, LATCH Breastfeeding Diagnostic Scale and Breastfeeding Self-Efficacy Scale-Short Form.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
32 Weeks 至 35 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Postmenstrual age 32 and 35 weeks of gestation,
  • Over 1500 g,
  • Switching to oral feeding after feeding with orogastric tube,
  • Who has been breastfed during gavage feeding,
  • Those who have not completed the first 24 hours in the transition from oragastric tube feeding to the oral feeding process,
  • Having cues of readiness for feeding (tolerating enteral nutrition, having a stable oxygen saturation and breathing during feeding, having the ability to lick, swallow and suck, react when mouth and lip are given stimuli),
  • The mother's willingness to breastfeed her baby,
  • Premature babies of parents who volunteered to participate in the study will be included.

排除标准

  • Having diseases other than being premature
  • Able to successfully take the breast in the first attempt,
  • Congenital anomaly,
  • Chromosomal disorders,
  • Having sepsis
  • With intracranial bleeding,
  • Those with a very low birth weight below 1500 g and
  • Less than 32nd gestational week,
  • Premature babies older than 35 weeks of gestation will be excluded.

结局指标

主要结局

LATCH a breastfeeding charting system and documentation tool

时间窗: 1 hours

LATCH is a diagnostic tool whose scoring system is similar to the Apgar score system. The scale consists of five evaluation criteria. The LATCH diagnostic tool is formed from the English initials of these five criteria. For each criterion that makes up the LATCH Breastfeeding Diagnostic and Evaluation Scale, 0,1, 2 points are given. Breastfeeding success is evaluated by summing the scores. The highest score that can be obtained from the scale is 10 and the lowest score is 0. The higher the score obtained from the scale, the higher the success of breastfeeding. In the research, the mother and her baby will be observed and evaluated while breastfeeding.

Breastfeeding Self-Efficacy Short Form Scale

时间窗: 1 hours

The scale is in 5-point Likert type and the items of the scale are evaluated by grading from 1 "I am not sure" to 5 "I am always sure". The lowest score that can be obtained from the scale is 14, and the highest score is 70. A high score on the scale indicates higher breastfeeding self-efficacy.

次要结局

未报告次要终点

研究者

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

Hilal Berber Çiftci

İstanbul Medipol University

Medipol University

研究点 (2)

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