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Randomized controlled trial protocol to improve multisensory neural processing, language and motor outcomes in preterm infants
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 ar...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6423745/ https://www.ncbi.nlm.nih.gov/pubmed/30890132 http://dx.doi.org/10.1186/s12887-019-1455-1 |
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author | Neel, Mary Lauren Yoder, Paul Matusz, Pawel J. Murray, Micah M. Miller, Ashley Burkhardt, Stephanie Emery, Lelia Hague, Kaleigh Pennington, Caitlin Purnell, Jessica Lightfoot, Megan Maitre, Nathalie L. |
author_facet | Neel, Mary Lauren Yoder, Paul Matusz, Pawel J. Murray, Micah M. Miller, Ashley Burkhardt, Stephanie Emery, Lelia Hague, Kaleigh Pennington, Caitlin Purnell, Jessica Lightfoot, Megan Maitre, Nathalie L. |
author_sort | Neel, Mary Lauren |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-6423745 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-64237452019-03-28 Randomized controlled trial protocol to improve multisensory neural processing, language and motor outcomes in preterm infants Neel, Mary Lauren Yoder, Paul Matusz, Pawel J. Murray, Micah M. Miller, Ashley Burkhardt, Stephanie Emery, Lelia Hague, Kaleigh Pennington, Caitlin Purnell, Jessica Lightfoot, Megan Maitre, Nathalie L. BMC Pediatr Study Protocol 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. BioMed Central 2019-03-19 /pmc/articles/PMC6423745/ /pubmed/30890132 http://dx.doi.org/10.1186/s12887-019-1455-1 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Neel, Mary Lauren Yoder, Paul Matusz, Pawel J. Murray, Micah M. Miller, Ashley Burkhardt, Stephanie Emery, Lelia Hague, Kaleigh Pennington, Caitlin Purnell, Jessica Lightfoot, Megan Maitre, Nathalie L. Randomized controlled trial protocol to improve multisensory neural processing, language and motor outcomes in preterm infants |
title | Randomized controlled trial protocol to improve multisensory neural processing, language and motor outcomes in preterm infants |
title_full | Randomized controlled trial protocol to improve multisensory neural processing, language and motor outcomes in preterm infants |
title_fullStr | Randomized controlled trial protocol to improve multisensory neural processing, language and motor outcomes in preterm infants |
title_full_unstemmed | Randomized controlled trial protocol to improve multisensory neural processing, language and motor outcomes in preterm infants |
title_short | Randomized controlled trial protocol to improve multisensory neural processing, language and motor outcomes in preterm infants |
title_sort | randomized controlled trial protocol to improve multisensory neural processing, language and motor outcomes in preterm infants |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6423745/ https://www.ncbi.nlm.nih.gov/pubmed/30890132 http://dx.doi.org/10.1186/s12887-019-1455-1 |
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