Effects of the Oral Stimulation Program in Extreme Preterm Infants
Effects of the Oral Stimulation Program in Extreme Preterm Infants: A Randomized Clinical Trial
研究概览
详细说明
Recent studies have suggested that an oral stimulation program applied to preterm infants facilitates their oral feeding progress, improve breastfeeding rates in preterm infants and decreases the length of hospital stay. The objective of this study will evaluate the effect an oral stimulation program on the performance feeding, the length of the transition oral feeding, length of hospital stay and breastfeeding rates upon discharge.
Primarily, will be evaluated the effect an oral stimulation program on the performance feeding. All infants will be assessed by a speech pathologist blinded as to the group randomization.
Secondarily, will be observed the length of the transition oral feeding of the preterm infants, conducted by medical team and will be observed length of hospital stay. Both groups will be monitored from when they were assigned to participate in the study until hospital discharge.
All statistical will be conducted using Statistical Package for Social Sciences® version 18.0. The data will be analyzed for treatment group differences with chi-square or Fisher's exact tests for the categorical variables and with non-parametric tests for the continuous variables.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Rio Grande do Sul
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Porto Alegre、Rio Grande do Sul、巴西
- Hospital de Clínicas de Porto Alegre
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- infants with between 26 and 32 weeks gestational age as determined by date of last menstruation and first trimester ultrasound or by clinical examination.
Exclusion Criteria:
- infants with medical complications, such as grades III or IV intraventricular hemorrhage or periventricular leukomalacia
- congenital diseases such as chromosomal or genetic abnormalities
- bronchopulmonary dysplasia
- necrotizing enterocolitis.
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Intervention group
Oral stimulation program consists of the a 15 minutes stimulation program, whereby the first 12 minutes involved stroking the cheeks, lips, gums, and tongue, and the final 3 minutes consists of sucking on a pacifier routinely.
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Oral stimulation program consists of the a 15 minutes stimulation program, whereby the first 12 minutes involved stroking the cheeks, lips, gums, and tongue, and the final 3 minutes consists of sucking on a pacifier routinely.
其他名称:
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假比较器:Control group
sham stimulation program consists of the same researcher placing her hands for 15 minutes.
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sham stimulation program consists of the same researcher placing her hands for 15 minutes.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Oral feeding performance
大体时间:20 minutes
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The volume transfer is as considered as the percentage of the volume consumed (%).
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20 minutes
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Oral feeding transition time
大体时间:60 days
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number of days
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60 days
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Days hospital stay
大体时间:6 months
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number of days
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6 months
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合作者和调查者
调查人员
- 首席研究员:Rita C Silveira, Professor、Neonatal Section
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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