Abstract
BackgroundPremature 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.MethodsThis 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.DiscussionThis 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 registrationNIH Clinical Trials (clinicaltrials.gov): NCT03232931. Registered July 2017.
Highlights
MethodsThis 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
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
Almost all preterm infants suffer from atypical brain maturation and its developmental consequences resulting from interactions between brain immaturity and premature extra-uterine sensory experience [8,9,10,11,12,13,14,15]
Summary
Study design In order to test these aims, we will conduct an RCT of a multisensory (MS) intervention with 200 hospitalized preterm infants in our Level IV NICU (Fig. 1). Multisensory intervention The MS intervention will be carried out in addition to standard care and will include the following components: holding and light pressure containment of the infant against the hospital-gown covered chest of the therapist for tactile and non-specific auditory stimulation simultaneous with playing of the mother’s voice contingent on infant pacifier sucking for the first 20 min of holding [68]. Statistical analysis Our first aim is to demonstrate that preterm infants receiving a standardized multisensory auditory-tactileolfactory-vestibular intervention in addition to standard of care in the NICU will have more typical cortical multisensory processing at discharge and better sensory adaptation and motor and language outcomes than infants receiving only standard of care. Statistical power With regards to the a-path, the sample-size-adjusted standardized mean difference on speech processing effect size from the contingent parent-voice versus control. A data safety monitoring committee consisting of the principal investigator, study coordinator, NICU nursing clinical leader, clinical program manager of developmental therapists in the NICU, and a parent of a NICU graduate on the parent advisory committee will further oversee the ongoing study
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
