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Randomized controlled trial protocol to improve multisensory neural processing, language and motor outcomes in
Mary Lauren Neel1, Paul Yoder2, Pawel J Matusz3,4
1Nationwide Children's Hospital Division of Neonatology & Center for Perinatal Research, The Ohio State University, 5th floor; 575 Children's Crossroads, Columbus, OH, 43215, USA. marylauren.neel@nationwidechildrens.org.
Insights
This study investigates a multisensory intervention for premature infants to improve sensory development. The intervention aims to enhance neurodevelopmental outcomes in high-risk infants, potentially improving long-term health.
Area of Science:
- Neonatal neuroscience
- Developmental pediatrics
- Sensory processing research
Background:
- Premature infants face risks to sensory development due to immature brains and NICU environments.
- Altered sensory development in preterm infants can negatively impact complex developmental processes.
- Current interventions do not specifically target sensory function rehabilitation during the neonatal period.
Purpose of the Study:
- To evaluate the efficacy of a novel multisensory intervention for preterm infants.
- To assess the impact of multisensory stimulation on brain-based measures of sensory processing.
- To determine if the intervention improves neurodevelopmental outcomes in former preterm infants.
Main Methods:
- A randomized controlled trial involving 200 preterm infants (32-36 weeks postmenstrual age).
- Intervention group received standard care plus multisensory stimulation (tactile, auditory, olfactory, vestibular).
- Primary outcome measured by time-locked EEG for multisensory processing; secondary outcomes assessed at 1-2 years corrected age.
Main Results:
- This section is not available in the provided abstract.
Conclusions:
- This is the first RCT using brain-based measures to assess a multisensory intervention's effect on preterm infant neurodevelopment.
- The protocolized intervention, therapist-administered and parent-supported, shows potential for wide NICU implementation.
- The findings may improve neurodevelopmental outcomes for premature infants through enhanced sensory processing.
Background:
Premature infants are at risk for abnormal sensory development due to brain immaturity at birth and atypical early sensory experiences in the Neonatal Intensive Care Unit. This altered sensory development can have downstream effects on other more complex developmental processes. There are currently no interventions that address rehabilitation of sensory function in the neonatal period.
Methods:
This study is a randomized controlled trial of preterm infants enrolled at 32-36 weeks postmenstrual age to either standard care or standard care plus multisensory intervention in order to study the effect of multisensory intervention as compared to standard care alone. The study population will consist of 100 preterm infants in each group (total n = 200). Both groups will receive standard care, consisting of non-contingent recorded parent's voice and skin-to-skin by parent. The multisensory group will also receive contemporaneous holding and light pressure containment for tactile stimulation, playing of the mother's voice contingent on the infant's pacifier sucking for auditory stimulation, exposure to a parent-scented cloth for olfactory stimulation, and exposure to carefully regulated therapist breathing that is mindful and responsive to the child's condition for vestibular stimulation. The primary outcome is a brain-based measure of multisensory processing, measured using time locked-EEG. Secondary outcomes include sensory adaptation, tactile processing, speech sound differentiation, motor and language function, measured at one and two years corrected gestational age.
Discussion:
This is the first randomized controlled trial of a multisensory intervention using brain-based measurements in order to explain the causal effects of the multisensory intervention on neural processing changes to mediate neurodevelopmental outcomes in former preterm infants. In addition to contributing a critical link in our understanding of these processes, the protocolized multisensory intervention in this study is therapist administered, parent supported and leverages simple technology. Thus, this multisensory intervention has the potential to be widely implemented in various NICU settings, with the opportunity to potentially improve neurodevelopment of premature infants.
Trial Registration:
NIH Clinical Trials ( clinicaltrials.gov ): NCT03232931 . Registered July 2017.
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