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临床试验/NCT04946045
NCT04946045已完成不适用

The Effect of Sensorimotor Interventions on Feeding Readiness and Oral Feeding Success in Preterm Infants : A Randomized Controlled Study

Pamukkale University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Oral Feeding Readiness

研究概览

简要总结

To examine the effects of sensorimotor interventions applied to in preterm infants on readiness for feeding and oral feeding success.

详细描述

The preterm neonate population cannot potentially be fed orally for a long time in the postnatal period. However, the inability of preterm infants to be fed orally as soon as they are born is not a disease, their adaptation to the external environment of the uterus is more complicated because their physiological functions are not yet mature. This also means long hospital stays for premature babies. Therefore, the American Academy of Pediatrics (AAP) has determined that oral feeding is one of the main criteria for the discharge of the preterm infant from the hospital.

Many studies have been conducted on preterm infants on optimizing oral feeding performance. Studies improve oral feeding skills of preterm infants by applying various sensorimotor interventions and cue-based feeding protocols to improve oral feeding performance. These sensorimotor interventions; non-nutritive sucking (pacifier), sucking-swallowing exercises, oral support, oral stimulation, tactile stimulation, kinesthetic stimulation, sound, smell, audio-visual stimulations, etc. methods were used alone or in combination with these methods.

It has been shown in studies that sensorimotor interventions increase the success of oral feeding in preterms, increase the daily feeding volume, increase weight gain, reduce the cost by shortening the hospital stay, shorten the transition time from gastric feeding to oral/breastfeeding and help mother-infant bonding.

This thesis study was conducted using evidence-based interventions that can facilitate the development of oral feeding skills in preterm infants, the feeding problems they encounter, and their transition from gastric feeding to oral feeding.

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
Double (Participant, Outcomes Assessor)

盲法说明

The "stratified block randomization" method was used to determine which group the preterm infants to be included in the study would be in.

Stratification was based on gestational age. The phase of inclusion in the study and control groups was carried out by another investigator in order to avoid study bias with block randomization.

入排标准

年龄范围
30 Weeks 至 33 Weeks(Child)
性别
All
接受健康志愿者
是

入选标准

  • •The mother's milk
  • •Preterm babies with a gestational age of 30-33 weeks
  • •No facial deformity,
  • •No respiratory, cardiovascular, gastrointestinal and neurological disorders or syndromes that would prevent or complicate oral feeding,
  • •No need for oxygen support,
  • •There will be preterm infants who are not fed orally, but who are started with tube (Orogastric) feeding.

排除标准

  • •Transferred to another center during the research,
  • •Unexpected complication development during the research,
  • •Occurrence of a pathology that will prevent or complicate oral feeding,
  • •In cases where there is no voluntary consent of the parent
  • •The mother is Covid positive

研究组 & 干预措施

İntervention (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking) Group

Experimental
  1. Tactile/Kinesthetic Stimulation (15 min): It was applied 3 times a day, once every 3 hours for 10 days.
  2. Nonnutritive Sucking: It was applied 8 times a day for 10 days with Orogastric (OG) feeding throughout the feeding.

干预措施: Sensorimotor Interventions (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking) (Other)

Control (Nonnutritive Sucking) Group

No Intervention
  1. Nonnutritive Sucking: Administered during feeding with Orogastric (OG) 8 times a day for 10 days.

结局指标

主要结局

Oral Feeding Readiness

时间窗: 10 days change in T-POFRAS (feeding readiness) after sensorimotor intervention.

Turkish version of the Preterm Oral Feeding Readiness Assessment Scale (T-POFRAS):It was administered to in preterm infants before and after 10 days of intervention by a neonatal nurse independent of the researcher.

次要结局

  • Oral Feeding Success(Change in oral feeding success level according to the 12-day six-phase feeding progression protocol)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zühal Çamur

RN, PhD

Pamukkale University

研究点 (1)

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