Nurturing and Quiet Intervention (NeuroN-QI) on Preterm Infants' Neurodevelopment and Maternal Stress and Anxiety: Protocol of a Pilot Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Feasibility and acceptability of the NeuroN-QI and the study procedures as assessed by a self-completed questionnaire (mothers) and a logbook (RA)
研究概览
简要总结
The current state of knowledge reveals that the development of the brain of preterm infants is influenced by specific neonatal experiences during hospitalization, such as environmental sensory stimulation (light and noise), as well as physical and emotional proximity to mothers. However, there is a lack of evidence regarding the benefits that could be associated with the combination of care interventions to improve the health outcomes of preterm infants and their mothers, and in particular the development of the brain of infants during their hospitalization in the neonatal unit. The aim of this pilot study is to assess the feasibility and acceptability of a developmental care intervention including periods of nurturing between mothers and their infant (skin-to-skin contact and auditory stimulation) to promote physical and emotional proximity and a quiet period (controlled light and noise levels and olfactory stimulation in incubators) and to estimate the effect of this intervention on infants' neurodevelopment as well as on maternal stress and anxiety.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 26 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •born between 26 and 316/7 WGA.
- •agree to do 4 SSC sessions/week with a 15-minutes period of auditory (reading) stimulation;
- •express breast milk for their infant;
- •speak, read, or write French or English.
- •have at least 6 months of work experience in a NICU;
- •speak and read French or English.
排除标准
- •have birth defects or genetic disorders;
- •have an intraventricular hemorrhage > grade II;
- •receive nasal respiratory support;
- •have been transferred from another hospital.
- •are <18 years of age;
- •had a multiparous birth;
- •have a physical condition that does not allow SSC;
- •abuse substances or alcohol;
- •do not intend to breastfeed or give breastmilk.
结局指标
主要结局
Feasibility and acceptability of the NeuroN-QI and the study procedures as assessed by a self-completed questionnaire (mothers) and a logbook (RA)
时间窗: 1 year
questionnaire completed by mothers - each question treated separately (no total score) Log book completed by a research assistant
次要结局
- Estimated effects of NeuroN-QI on maternal stress as assessed by PSS:NICU(1 year)
- Feasibility of the NeuroN-QI as assessed by a self-completed questionnaire(1 year)
- Estimated effects of NeuroN-QI on infants' neurodevelopment as assessed using the General Movements Assessment (GMA)(1 year)
- Estimated effects of NeuroN-QI on maternal anxiety as assessed by STAI-Y(1 year)
- Acceptability of the NeuroN-QI as assessed by a self-completed questionnaire(1 year)
- Estimated effects of NeuroN-QI on infants' neurodevelopment as assessed using the Assessment of Preterm Infants Behavior (APIB)(1 year)
- Nurses' training needs about the NeuroN-QI as assessed by a self-completed questionnaire(1 year)
研究者
Marilyn Aita
Associate Professor & Researcher
Université de Montréal