Impact of Early Oral Stimulation on Reducing Cardiorespiratory Events and Transition to Oral Feeding in Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- the cardiorespiratory manifestations
研究概览
简要总结
To assess whether an oral stimulation program, before the introduction of oral feeding, enhances the cardiorespiratory manifestations (episodes of oxygen désaturations, and/or apnea- bradycardia), and the oral feeding performance, in preterm infants born between 26 to 29 weeks of gestation age.
详细描述
Preterm infant were randomized into an experimental or an control group. Infants in the experimental group receive an oral stimulation program consisting of stimulation of the oral structures during 10 consecutive days. Infant in the control group receive no stimulation only non nutritive sucking during feeding. Both were administered twice per day, during 20 minutes, 48 hours after discontinuation of nasal continuous positive air pressure. A long term evaluation of oral feeding difficulties and neuromotor development are organized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 29 Weeks 至 33 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children whose born term is included between 26 and 29SA past and whose postnatal age is lower or more equal in 33SA past, at the time of the inclusion.
- •Term of certain child (calculated according to the date of the last rules and\or a premature obstetric echography).
- •Children devoid of neurological pathology making him(it) clinically unstable (echography transfontanellar and\or intellectual MRI, electroencephalogram normal, either, intraventricular bleeding of rank 1 and 2 of Papile [40], or, intellectual abnormalities in the MRI of type(chap) 1 - 4 according to the classification of modified Paneth [41]. (Annex X)
- •Children devoid of infectious pathology making him(it) clinically unstable (Protein C-reactive lower than 7).
- •In case of ebb gastroenteritis - esophageal symptomatic ( RGO): the child will be treated(handled), by oral route, by location + thickening +/-prokinetic +/-inhibitor pumps in proton.
- •According to a protocol of service, all the premature babies of less than 32.
排除标准
- •Born Child > 29 limited companies.
- •Child not included at the postnatal age of 33 past(over) LIMITED COMPANIES.
- •Child presenting a genic syndrome, an evolutionary neurological disease, a pathology malformative.
- •Child presenting a bleeding intraventricular of rank 3-4 [ 40 ], intellectual abnormalities in the MRI of type(chap) 5 and 6 according to the classification of modified Paneth [ 41 ], an ulcer-necrotizing entérocolitis.
- •Child among whom both relatives(parents) or legal representatives refused that their child participates in the study.
结局指标
主要结局
the cardiorespiratory manifestations
时间窗: 2 years
to assess whether an oral stimulation program, before the introduction of oral feeding, enhances the cardiorespiratory manifestations
次要结局
- the oral feeding performance(2 years)