Faculty of Nursing, Université de Montréal, Montréal, Canada.
CHU Sainte-Justine Research Centre, Montréal, Canada.
J Adv Nurs. 2021 Jul;77(7):3192-3203. doi: 10.1111/jan.14819. Epub 2021 Mar 14.
Primary objective of this pilot study is to evaluate the feasibility and acceptability of the NeuroN-QI and the study procedures. Secondary objectives are to assess the feasibility and acceptability of the NeuroN-QI by the nurses, assess the nurses' training needs about the components of the NeuroN-QI, and estimate the preliminary effects of the NeuroN-QI on infants' neurodevelopment as well as maternal stress and anxiety at infants' 36 weeks of gestational age.
A two-group pilot parallel randomized clinical trial stratified by center.
The pilot study will be conducted in two neonatal intensive care units (NICUs). A sample of 24 mother-infant dyads born between 26 and 31 gestational age will be randomized into an experimental or control group. Fifty nurses will be recruited. The NeuroN-QI consists of four 2-hour skin-to-skin contact sessions/week with a 15-minute auditory stimulation by mothers with controlled ambient levels of light and noise. A 1-hour quiet period will follow where infants will rest in their incubator/crib with their mother's milk for olfactory stimulation and where the light and noise control will be continued. In the control group, mother-infant dyads will do four skin-to-skin contacts per week and receive standard care. Acceptability and feasibility of the NeuroN-QI in addition to maternal stress and anxiety will be measured through questionnaires, while infants' neurodevelopment will be assessed with Assessment of Preterm Infant Behaviour and General Movement Assessment.
This pilot trial will address knowledge gaps and generate evidence in neonatal care by evaluating the feasibility and acceptability of a multi-component developmental care intervention.
This project is an innovative step towards optimizing the neurodevelopmental trajectory of infants in NICUs and consequently promoting their long-term health outcomes.
NCT04593095.
本研究的主要目的是评估 NeuroN-QI 的可行性和可接受性以及研究程序。次要目的是评估护士对 NeuroN-QI 的接受程度和可行性，评估护士对 NeuroN-QI 各组成部分的培训需求，以及估计 NeuroN-QI 对婴儿神经发育以及母亲在婴儿 36 孕周时的应激和焦虑的初步影响。
按中心分层的两组平行随机临床试验。
该研究将在两个新生儿重症监护病房（NICU）进行。将招募 24 对母婴二联体，其出生胎龄在 26 至 31 周之间，随机分为实验组或对照组。将招募 50 名护士。NeuroN-QI 由每周 4 次、每次 2 小时的皮肤接触和母亲进行 15 分钟听觉刺激组成，控制环境的光照和噪声水平。随后是 1 小时安静期，在此期间，婴儿将在培养箱/婴儿床中休息，母亲的母乳提供嗅觉刺激，同时继续控制光照和噪声。在对照组中，母婴二联体每周进行 4 次皮肤接触，并接受标准护理。NeuroN-QI 的可接受性和可行性以及母亲的应激和焦虑将通过问卷调查进行测量，而婴儿的神经发育将通过早产儿行为评估和一般运动评估进行评估。
该试验将通过评估多组分发育护理干预的可行性和可接受性，解决新生儿护理方面的知识空白并提供证据。
该项目是优化新生儿重症监护病房婴儿神经发育轨迹的创新步骤，从而促进他们的长期健康结果。
NCT04593095。
