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临床试验/NCT04751903
NCT04751903已完成不适用

The Effect of Oral Motor Stimulation on Feeding and Sucking in Preterm Infants

Bozok University2 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2017年5月5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
77
试验地点
2
主要终点
LATCH Breastfeeding Assessment Tool

研究概览

简要总结

This study aimed to determine the effect of oral motor stimulation (OMS) in preterm infants for successful feeding and sucking.

详细描述

In recent years, with advances in methods of neonatal resuscitation and caring methods, the survival rate of preterm infants has gradually increased. Sucking, swallow and respiratory dysfunction are widespread complications in the preterm infants that reason oral feeding difficulties. Safe and successful oral feeding requires proper maturation of sucking, swallowing, and respiration. The development of behaviors necessary for safe and successful nutrition begins long before birth. Jaw movements begin to be seen in the intrauterine 11th week. But sucking-swallowing-respiratory coordination is not sufficiently developed before 34 weeks of gestation. For this reason, preterm babies at the greater gestational week usually show more developed and consistent feeding skills. Maternal breast milk is best for neurodevelopment in preterm infants. Achieve oral feeding and maternal breast milk as early as possible is beneficial for preterm infants.

Oral motor stimulation (OMS) is defined as the sensorial stimulation of cheek, lip, jaw, upper-lower gum, internal cheek, tongue and soft palate that affects the physiology of oropharyngeal mechanisms and develops feeding functions. OMS used as an alternative or supplementary early intervention strategy to develop oral feeding skills in preterm infants. Previous studies have indicated that the use of OMS during or before the transition to oral feeding may not only have positive effects on the preterm infants' feeding behaviors but also enhance their general clinical course. Preterm infants who suffer from oral feeding problems often experience longterm health problems and delayed discharge from the hospital. A more effective feeding decreases adverse outcomes by decreasing hospital stays.

Preterm infants are required to prolonged NICU stay in order to stabilized, feeding, and gain optimal weight. Increasing prematurity and reduced birth weight lead to extensive resource utilization. In addition all nutritional options except breast milk increase the cost. OMS can develop sucking success and provide early oral feeding. Thus nurse labor and hospital costs may decrease and OMS can be a cost-effective application.

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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)

盲法说明

The study was conducted at neonatal intensive care unit (NICU) of the university hospital located in eastern Turkey between May 5th, 2017 and March 19th, 2018. The preterm infants were randomly allocated to two groups, experimental group and control group, by a computer-generated number table. The sample consisted of 77 preterm infants (39 in the experimental group and 38 in the control group) who met the inclusion criteria. The gestational weeks when babies are born were grouped as follows: 29-30 weeks, 31-32 weeks, and 33-34 weeks. In this study, only one researcher (1st author) who was not included in the intensive care team administered OMS to all the infants. Thus, the families and the NICU team were double-blinded.

入排标准

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

入选标准

  • Born between 29th and 34th gestational weeks, based on the mother's last menstruation date,
  • Percentile measurements consistent with their gestational week measurements,
  • Stable vital signs,
  • APGAR scores between 4 and 10 in the 1st and 5th minutes,
  • Stable for 48 hours after having received mechanical ventilation and/or continuous positive airway pressure,
  • Being breastfed,
  • Mother's eagerness to breastfeed the infant,
  • Voluntary participation of parents in the study.

排除标准

  • Suffered from severe asphyxia,
  • Born with a low birth weight according to gestational week,
  • Have intraventricular bleeding,
  • With a congenital anomaly,
  • Babies without their mother.

结局指标

主要结局

LATCH Breastfeeding Assessment Tool

时间窗: 36th gestational week , 5 minute

It was developed by Jensen, Wallace, \& Kelsay (1994). Demirhan (1997) conducted its Turkey validity test and revealed that it is a reliable and easy-to-use scale. Each criterion is rated in the point range of 0-2 points. Breastfeeding is then assessed based on the sum of these scores. The highest and lowest scores of the tool are 10 and 0, respectively, and higher scores signify breastfeeding/sucking success.

body weight

时间窗: 36th gestational week ,3 minute

The baby's body weight is weighed in grams with a digital scale.

head circumference

时间窗: 36th gestational week ,1 minute

The baby's head circumference is measured in cm with a tape measure.

length

时间窗: 36th gestational week,1 minute

The baby's length is measured in cm with a tape measure.

次要结局

未报告次要终点

研究者

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

Şenay ARAS DOĞAN

Assistant Professor

Bozok University

研究点 (2)

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