Lavallée Andréane, Aita Marilyn, Côté José, Bell Linda, Luu Thuy Mai
Faculty of Nursing, Université de Montréal, Montréal, Canada.
CHU Sainte-Justine Research Centre, Montréal, Canada.
Pilot Feasibility Stud. 2020 May 26;6:77. doi: 10.1186/s40814-020-00601-5. eCollection 2020.
In the NICU, interventions intended to enhance maternal sensitivity are indicated in order to optimize preterm infant development and long-term mother-infant attachment. A novel nursing intervention was developed following a theory-oriented methodology and is based upon the guided participation theory for mothers to participate in their preterm infant's therapeutic POSITioning and care (GP_Posit). The primary objective of this study is to evaluate the feasibility and acceptability of (i) the study design; and (ii) the experimental GP_Posit nursing intervention during NICU hospitalization. The secondary objective is to estimate the preliminary effects of GP_Posit on maternal and preterm infant outcomes.
A pilot parallel-group randomized clinical trial (RCT) was designed where mother-preterm infant dyads are being recruited and randomized to a control group (usual care) or experimental group (GP_Posit intervention). Data collection includes feasibility and acceptability data as well as preliminary effects on maternal sensitivity and infant neurodevelopment. Ethical approval from the University Hospital ethical board was obtained in January 2018 (2017-1540).
Data collection for this pilot study is expected to end in 2020. Results of this pilot study will inform about the feasibility and acceptability of the study design and GP_Posit intervention, a nursing intervention having the potential to favor maternal sensitivity and infant neurodevelopment in the NICU and guide the elaboration of a large-scale RCT.
clinicaltrial.gov, NCT03677752. Registered 19 September 2018.
在新生儿重症监护病房（NICU），为优化早产儿发育及母婴长期依恋关系，需采取旨在提高母亲敏感性的干预措施。一项新颖的护理干预措施是按照以理论为导向的方法制定的，它基于引导参与理论，让母亲参与其早产儿的治疗性体位摆放和护理（GP_Posit）。本研究的主要目的是评估：（i）研究设计；以及（ii）NICU住院期间的实验性GP_Posit护理干预措施的可行性和可接受性。次要目的是估计GP_Posit对母亲和早产儿结局的初步影响。
设计了一项试点平行组随机临床试验（RCT），招募母婴二元组并随机分为对照组（常规护理）或实验组（GP_Posit干预）。数据收集包括可行性和可接受性数据以及对母亲敏感性和婴儿神经发育的初步影响。2018年1月获得了大学医院伦理委员会的伦理批准（2017 - 1540）。
预计该试点研究的数据收集将于2020年结束。该试点研究的结果将为研究设计和GP_Posit干预的可行性和可接受性提供信息，这是一种有可能促进NICU中母亲敏感性和婴儿神经发育的护理干预措施，并指导大规模RCT的制定。
clinicaltrial.gov，NCT03677752。2018年9月19日注册。
