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Randomized controlled trial protocol to improve multisensory neural processing, language and motor outcomes in preterm infants.

ABSTRACT: 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.

SUBMITTER: Neel ML

PROVIDER: S-EPMC6423745 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Randomized controlled trial protocol to improve multisensory neural processing, language and motor outcomes in preterm infants.

Neel Mary Lauren ML Yoder Paul P Matusz Pawel J PJ Murray Micah M MM Miller Ashley A Burkhardt Stephanie S Emery Lelia L Hague Kaleigh K Pennington Caitlin C Purnell Jessica J Lightfoot Megan M Maitre Nathalie L NL

BMC pediatrics 20190319 1

<h4>Background</h4>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.<h4>Methods</h4>This study is a randomized controlled trial of preterm infants enrolled at 32 ...[more]

PMID: 30890132

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Project description:Knowledge about early physiotherapy to preterm infants is sparse, given the risk of delayed motor development and cerebral palsy.A pragmatic randomized controlled study has been designed to assess the effect of a preventative physiotherapy program carried out in the neonatal intensive care unit. Moreover, a qualitative study is carried out to assess the physiotherapy performance and parents' experiences with the intervention. The aim of the physiotherapy program is to improve motor development i.e. postural control and selective movements in these infants. 150 infants will be included and randomized to either intervention or standard follow-up. The infants in the intervention group will be given specific stimulation to facilitate movements based on the individual infant's development, behavior and needs. The physiotherapist teaches the parents how to do the intervention and the parents receive a booklet with photos and descriptions of the intervention. Intervention is carried out twice a day for three weeks (week 34, 35, 36 postmenstrual age). Standardized tests are carried out at baseline, term age and at three, six, 12 and 24 months corrected age. In addition eight triads (infant, parent and physiotherapist) are observed and videotaped in four clinical encounters each to assess the process of physiotherapy performance. The parents are also interviewed on their experiences with the intervention and how it influences on the parent-child relationship. Eight parents from the follow up group are interviewed about their experience. The interviews are performed according to the same schedule as the standardized measurements. Primary outcome is at two years corrected age.The paper presents the protocol for a randomized controlled trial designed to study the effect of physiotherapy to preterm infants at neonatal intensive care units. It also studies physiotherapy performance and the parent's experiences with the intervention.ClinicalTrials.gov NCT01089296.

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Randomized controlled trial protocol to improve multisensory neural processing, language and motor outcomes in preterm infants.

Publications

Randomized controlled trial protocol to improve multisensory neural processing, language and motor outcomes in preterm infants.

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