跳至主要内容
临床试验/NCT05036915
NCT05036915已完成不适用

The Effect of Routine and Random Pacifier Use Methods in Preterm Infants on Transition to Bottle Feeding Process

Acibadem University1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2021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
43
试验地点
1
主要终点
Change in body weight

研究概览

简要总结

The aim of this study is to determine the effect of the routine 5-min pacifier use before feeding and the random 30-min pacifier use independent from feeding during the day on the transition to bottle feeding process in preterm infants.

详细描述

Preterm infants, may most frequently experience feeding difficulties as a result of lower oral-motor tone, poor coordination during sucking-swallowing-respiration, sleepy behavior, gastrointestinal dysmotility and immature sucking pressure and being unable to sustain their physiological values at a normal level during feeding. In the literature, it is reported that approximately 82% of preterm infants have an oral feeding difficulty. As a consequence, it is a very complex process to acquire a safe and effective feeding skill and preterm infants need support in the weeks after birth until participants develop skills that are necessary for oral feeding and complete a successful transition to total oral feeding independent from orogastric catheter.

Although studies have stressed positive effects of the Non-nutritive sucking (NNS) intervention on feeding performance, it is reported that there is a need for more comprehensive randomized controlled studies revealing the use frequency, duration or effect of time.

In the Neonatal Intensive Care Unit (NICU) where the study will be conducted, an appropriate method is chosen for preterm infants based on their general condition and the feeding transition stages are determined incrementally with repetitive follow-ups during feeding. The routine 5-min pacifier use method before feeding and the random 30-min pacifier use method during the day will be applied to newborns who have enteral feeding. Newborns who already use pacifier independent from feeding during the day in the clinic and to whom these methods are applied, will comprise the control group. In order to ensure a homogeneous application in the control group, the pacifier use duration will be limited to 30 minutes. Pacifier use durations have been determined in line with the literature examining the contribution of pacifier use to the feeding of preterm infants. Newborns, to whom the routine 5-min pacifier use method is applied before each feeding, will comprise the experimental group. All newborns included in the study will be followed until participants are discharged.

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
None

入排标准

年龄范围
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm infants;
  • Whose legal representatives agree to take part in the study and sign the informed consent form,
  • Who have a stable clinical picture,
  • Who are on the first day of enteral feeding will be included in the study.

排除标准

  • Preterm infants;
  • Who have a comorbidity,
  • Who are intubated,
  • Who have an inherent anomaly,
  • Who have parenteral feeding will not be included in the study.

结局指标

主要结局

Change in body weight

时间窗: From baseline to transition to total oral feeding (average15 weeks)

Participant's body weight will be assessed from baseline to transition to total oral feeding up to through study completion

Change in feed intake

时间窗: From baseline to transition to total oral feeding (average 15 weeks)

Change in feed intake will be assessed from baseline to transition to total oral feeding

Length of hospital stay

时间窗: From baseline to discharge (average 15 weeks)

The time from date of hospitalization until the date of discharge.

次要结局

未报告次要终点

研究者

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

Zehra Kan Onturk

Assist. Prof.

Acibadem University

研究点 (1)

Loading locations...

相似试验