Effects of the Premature Infant Oral Motor Intervention on the Oral Feeding Skills of the Premature Infants: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Mean volume
研究概览
简要总结
Randomized controlled clinical trial aimed at evaluating the effects of the "Premature infant oral motor intervention" method on the oral feeding skills of the premature infants.
详细描述
Numerous evidences emerge from the literature review on the usefulness of the PIOMI method to improve food skills in the premature infant. The goal of this study is to evaluate the effects of the PIOMI method by adding the gustatory stimulation to the original protocol.
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)
入排标准
- 年龄范围
- 25 Weeks 至 33 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gestational age at birth between 25-33 weeks;
- •clinical stability;
- •possible presence of nasogastric or oro-gastric tube;
- •non-invasive respiratory support (oxygen, high flows)
排除标准
- •gestational age <25 weeks or> 33 weeks
- •absence of clinical stability
- •invasive respiratory support (CPAP)
- •previous surgical interventions
- •ongoing infections
- •congenital and / or chromosomal diseases
- •brain, metabolic, cardiac, gastrointestinal diseases
- •presence of bronchopulmonary dysplasia
研究组 & 干预措施
PIOMI Group
Patients in this group will receive the intraoral and extraoral stimulations provided by the PIOMI protocol. These stimulations will last 5 minutes and will be performed once a day for 7 consecutive days for each patient.
干预措施: PIOMI (Other)
Control Group
Patients in this group will receive classic care.
结局指标
主要结局
Mean volume
时间窗: 7 days
Mean volume of oral intake
次要结局
- feeding efficiency(3 days)
- achievement of full oral feeding(6 moths)
- hospital stay time(6 months)
- transition time(6 months)