NCT05272956已完成不适用
Impact of Parental Involvement in Enteral Nutrition on Their Presence in Neonatal Units
University Hospital, Limoges2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2022年8月10日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- parental presence
研究概览
简要总结
- Hypothesis : Bolus feeding of the newborn with a syringe under parents' visual control increases parental presence when compared to enteral feeding with a syringe pump.
- Main criteria : Comparison of parental presence (mean time in hours) between the two arms : pushed bolus syringe feeding under parent's visual control and enteral feeding with a syringe pump.
详细描述
- Nutrition is the cornerstone of neonatology. Adequate nutrition is necessary for a healthy brain growth and a physiological development. When oral feeding skills are not acquired, enteral feeding is used via a nasogastric tube by an electric syringe pump. The birth a premature child jeopardizes parent-infant bonding and hinders parental feeding skills. Family-centered care has shown to be beneficial for the child and his parents by promoting early interactions, which lay the foundations for the child's psychological development. As such, pushed bolus enteral feeding by the parents with a syringe has been a common practice in Sweden since the 1980s to involve the parents in enteral feeding practices. In France, this practice has been used in neonatal intensive care units (NICU). Two French studies on this subject have been published. One focused on using parental pushed bolus enteral feeding in a hospitalization at home setting, whereas the other study investigated the impact of parental observation on pushed bolus enteral feeding. To our knowledge, there is no study proving the superiority of bolus feeding with a syringe under parents' visual control over enteral feeding with a syringe pump.
- This study is an open-label, randomized, comparative interventional study with an intention-to-treat analysis. We compared a control group (enteral nutrition with an electric syringe pump while the neonate is lying in a cocoon or carried by their parent) to an intervention group (pushed bolus enteral nutrition under parents' visual control)
- In the control group, enteral feeding used an electric syringe pump.
- In the intervention group, the first enteral feeding is pushed with a syringe by the nurse. Following enteral feeding attempts are pushed with a syringe by the parents only if they can or will grow. Bolus feeding speed is at the discretion of the person pushing the syringe (nurse or parent) and is adjusted to the child's signs of discomfort. When the parents are absent, enteral feeding is carried out with a syringe pump.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 3 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age between 30 and 34 WA (weeks of amenorrhea)
- •Patient affiliated to a social security scheme
- •Hospitalized in neonatal intensive care unit (NICU)
- •3 days of life or more
排除标准
- •Corrected age> 34WA and 4 days
- •Mechanical ventilation or non-invasive ventilation with FIO2> 35%
- •Serious congenital malformation
- •Planned transfer to another hospital
- •Enteral nutrition <40ml / kg / day
- •Immediate post-operative care
- •Multiple pregnancy
- •Poor understanding of french
- •Secondary exclusion criteria
- •Digestive rest greater than 5 days
- •No enteral nutrition pushed by parents
研究组 & 干预措施
control group
No Intervention
Enteral feeding is carried out with a syringe pump
intervention group
Experimental
the first enteral feeding is pushed with a syringe by the nurse. Following enteral feeding attempts are pushed with a syringe by the parents. Bolus feeding speed is at the discretion of the person pushing the syringe (nurse or parent) and is adjusted to the child's signs of discomfort. When the parents are absent, enteral feeding is carried out with a syringe pump
干预措施: enteral feeding with pushed syringe by the parents (Procedure)
结局指标
主要结局
parental presence
时间窗: from start to the end of enteral feeding, with a maximum of 10 weeks
Comparison of parental presence (mean time in hours) between the two arms: pushed bolus syringe feeding under parent's visual control and enteral feeding with a syringe pump
次要结局
- Mean daily skin-to-skin duration(from start to the end of enteral feeding, with a maximum of 10 weeks)
- Anxiety mean score for both parents (PARENTAL STRESSOR SCALE)(from start to the end of enteral feeding, with a maximum of 10 weeks)
- Mother-newborn bond assessment scale (MIBS) score(from start to the end of enteral feeding, with a maximum of 10 weeks)
- Corrected age at which oral feeding skills are acquired(from start to the end of enteral feeding, with a maximum of 10 weeks)
- Weight gain in g / kg / day during the study time(from start to the end of enteral feeding, with a maximum of 10 weeks)
- Percentage of breastfeeding at inclusion and at the end of the participation period(from start to the end of enteral feeding, with a maximum of 10 weeks)
- Adherence of pushed bolus syringue feeding under parent's visual control(from start to the end of enteral feeding, with a maximum of 10 weeks)
研究者
研究点 (2)
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