Efficacy of a Physiotherapy Intervention to Improve Feeding Skills in Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Transition time
研究概览
简要总结
INTRODUCTION: Suction problems are very common in premature children due to a lack of maturation and orofacial control, the manifestation of a low muscle tone and the incoordination during sucking-swallow-breathe. In addition, there are some problems in different systems that get it worse.
AIM: compare oral stimulation programme with a neurodevelopmental stimulation intervention programme combined with an oral stimulation programme, evaluating its effectiveness on feeding development, neuromotor development and other aspects of development.
METHODOLOGY: we proposed a prospective parallel group clinical trial with two randomized and independent experimental groups. All preterm infants born between 2022-2023 at University Hospital Torrecárdenas, with nasogastric tube and gestational age between 27-32 weeks will be included.
EXPECTED BENEFITS: to have better results when the preterm infant is approached globally, also considering the postural situation of the preterm infant. In addition, it is expected that the development of children treated by combining oral stimulation with neurodevelopmental stimulation will be equated or close to healthy and born-to-term child.
RESULTS APPLICABILITY: Improved eating performances will reduce length of hospital stay as well as a greater autonomy improving family situation. It will also allow the reduction of hospital costs and the creation of a new way to attend this problem in preterm children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 27 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Premature infants with a gestational age between 27 and 32 weeks, with an adequate weight for their gestational age, admitted to the unit of Neonatology, hemodynamically stable and with enteral nutrition
排除标准
- •Neurological disorders
- •Invasive mechanical ventilation
- •Congenital disorders
- •Necrotising enterocolitis
- •Metabolic diseases
- •Intraventricular hemorrhage grade 3-4
- •Genetic disorders
- •Oral disorders that make this process difficult(cleft palate, cleft lip...)
- •Serious illnesses according to medical criteria
研究组 & 干预措施
GEO+N
Neurodevelopmental stimulation intervention programme combined with an oral stimulation programme. They recives 10 sesions of 15 minutes of stimulation.
干预措施: Neurodevelopmental stimulation + Oral stimulation (Other)
GEO+N
Neurodevelopmental stimulation intervention programme combined with an oral stimulation programme. They recives 10 sesions of 15 minutes of stimulation.
干预措施: Oral stimulation (Other)
GEO
Oral stimulation programme. They recives 10 sesions of 15 minutes of stimulation.
干预措施: Oral stimulation (Other)
结局指标
主要结局
Transition time
时间窗: Two years
The transition time from tube to oral feeding. To complete this, the baby has to feed independently during two consecutive days.
次要结局
- Weight(Two years)
- OFEATINg (Oral FEeding Assessment in premaTure Infants)(Two years)
- Head circumference.(Two years)
- PERI(Two years)
- Feeding evolution(Two years)
- Height(Two years)
- Gross Motor Skills(Two years.)
- Neuromotor Development(Two years)
研究者
María del Mar Sánchez Joya
Associate Professor
Universidad de Almeria