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. 2021 Jul;77(7):3192-3203.
doi: 10.1111/jan.14819. Epub 2021 Mar 14.

Nurturing and quiet intervention (NeuroN-QI) on preterm infants' neurodevelopment and maternal stress and anxiety: A pilot randomized clinical trial protocol

Marilyn Aita  1   2   3 , Marjolaine Héon  1   3 , Andréane Lavallée  1   2   3 , Gwenaëlle De Clifford Faugère  1   2 , Gabriel Altit  4   5   6 , Sylvie Le May  1   2   3 , Véronique Dorval  7 , Sarah Lippé  2   8 , Audrey Larone Juneau  9 , Elissa Remmer  10 , Janet E Rennick  3   5   6   11   12
Affiliations

Nurturing and quiet intervention (NeuroN-QI) on preterm infants' neurodevelopment and maternal stress and anxiety: A pilot randomized clinical trial protocol

Marilyn Aita et al. J Adv Nurs. 2021 Jul.

Abstract

Objectives: 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.

Design: A two-group pilot parallel randomized clinical trial stratified by center.

Methods: The pilot study will be conducted in two neonatal intensive care units (NICUs). A sample of 24 mother-infant dyads born between 26 and 316/7 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.

Conclusions: 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.

Impact: This project is an innovative step towards optimizing the neurodevelopmental trajectory of infants in NICUs and consequently promoting their long-term health outcomes.

Trial registration: NCT04593095.

Keywords: NICU; anxiety; developmental care; intervention; mothers; neurodevelopment; nursing; pilot study; preterm infants; stress.

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