Multisensory Stimulation Bundles on Sleep and Neurobehavioral Development in the First Year After Birth in Very Preterm Infants: A Randomized Crossover Controlled Study Protocol (preprint)

ABSTRACT

Background This paper is a protocol for an evaluator-blinded, randomized crossover trial. It aims to assess the sleep efficiency of hospitalized very preterm infants (VPIs) by providing multisensory stimulation bundles. In addition, it will observe the intervention impacts on sleep during hospitalization and the sleep and neurodevelopmental outcomes during the first year of post-discharge follow-up.Methods The study will be conducted in the neonatology department of a tertiary pediatric teaching hospital. All eligible VPIs will undergo two types of care in random order “standard care” (2 weeks) and “standard care plus multisensory stimulation bundles” (2 weeks). A generated list of random numbers will be used for case sequence allocation. Sleep outcomes will be evaluated using the Actiwatch-2 Actigraph. Moreover, the amplitude-integrated electroencephalography and the Griffiths Mental Development Scales will be used to measure the neurodevelopmental outcomes during hospitalization and in the first year of follow-up of VPIs.Discussion The intervention protocol of this study differs from other traditional interventions by producing precise and consistent supportive stimulations, similar to the maternal tactile, auditory, posture, and visual effects for hospitalized preterm infants. This protocol could be an effective measure to facilitate sleep and early neurodevelopment of VPIs. The expected outcomes will help confirm implementing and generalizing of the multisensory stimulation bundles care protocol in neonatology departments. We expect the study to positively impact hospitalized VPIs, specifically for their sleep and early neurodevelopmental outcomes. The study will also provide a new perspective regarding parent and infant interaction strategies, particularly for newborn intensive care units that limit visits due to the global spread of COVID-19.Trial registration Chinese Clinical Trial Registry (Registry Number ChiCTR 2200059099), Registered 25 April 2022, https//www.chictr.org.cn/showproj.html?proj=166980