The long-term goal of this project is to improve the health and well-being of preterm infants and their parents. Although there is evidence to support positive multisensory interventions in the NICU, these interventions are often applied in an inconsistent manner, reducing their benefit. Through a rigorous and scientific process, we have developed a structured multisensory intervention program, titled Supporting and Enhancing NICU Sensory Experiences (SENSE), which includes specific doses and targeted timing of evidence-based interventions such as massage, auditory exposure, rocking, holding, and skin-to-skin care. The interventions are based on the infant's developmental stage and are adapted based on the infant's medical status and behavioral cues. The multisensory interventions are designed to be conducted during each day of NICU hospitalization by the parents, who are educated and supported to provide them. The proposed work aims to determine the effect of multisensory interventions on parent mental health, parent-child interaction, brain activity (amplitude integrated electroencephalography), and infant developmental outcomes through age 2 years, with specific attention to language outcome.
Two-hundred fifteen parent-infant dyads of preterm infants born ≤ 32 weeks gestation and admitted to a Level IV NICU (and associated Level III NICU) will be enrolled within 1 week of birth. Infants will be randomized to either the SENSE multisensory program or to the standard of care during the NICU stay. The SENSE program combines structured, easy-to-conduct, multisensory interventions with parent engagement to optimize outcomes in the complex medical environment of the NICU. Standardized assessments of parent mental health, infant neurodevelopment, and parent-child interaction will be conducted prior to NICU discharge and at 6 months, 1 year, and 2 years, adjusted for prematurity. Differences between groups will be investigated. Brain activity during NICU stay, including in the presence and absence of different sensory exposures, will also be investigated. The expected outcome is that the SENSE multisensory program will have a positive effect on improving outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
215
In order to support parent's ability to implement the daily SENSE program they will be provided with an educational manual reviewing the program, weekly meetings with a therapist, and logs to report their visitation schedule and activities. Parents are able to choose different types of each sensory exposure. All options address the same key principles for that behavior and only include those that have evidence to support their use and are appropriate at each PMA.
Infants who receive sensory exposures only as standard of care but do not recieve the SENSE program
Cardinal Glennon Children's Hospital
St Louis, Missouri, United States
RECRUITINGBayley Scales of Infant Toddler Development, 4th Edition
Standardized assessment of language, cognitive, and motor: language outcome is the primary outcome
Time frame: 2 years adjusted age
Bayley Scales of Infant Toddler Development, 4th Edition
Standardized assessment of language, cognitive, and motor
Time frame: 6 months and 1 year adjusted age (when completed in newborn follow-up clinic)
NICU Network Neurobehavioral Assessment Scale
Standardized neonatal neurobehavioral assessment
Time frame: Between 35-41 weeks PMA
Sensory Profile 2
Parent-report measure of sensory processing
Time frame: Prior to NICU discharge and at 6 months, 1 and 2 years adjusted age,
Modified Checklist for Autism in Toddlers
Parent report measure of sensory features
Time frame: 2 years adjusted age
Ages and Stages Questionnaire-3
parent report measure of development
Time frame: 6 months adjusted age, 1 and 2 years adjusted age
Child Behavior Checklist (CBCL)
Parent report measure of social emotional function
Time frame: 2 years adjusted
Emotional Availability Scales
Standardized observational assessment of parent-child interaction
Time frame: Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 2 years adjusted
State Trait Anxiety Inventory
Self report measure of anxiety
Time frame: Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 6 months, one and 2 years adjusted age
Life Stress Subscale of the Parenting Stress Index (PSI)
Self report measure of stress
Time frame: Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 6 months, one and 2 years adjusted age
Edinburgh Postnatal Depression Scale (EPDS)
Self report measure of maternal postpartum depression
Time frame: Prior to the infant's discharge from the NICU (35-41 weeks PMA)
aEEG Burdjalov Score
The Olympic Brainz Monitor (OBM) Monitor (TMNatus), which provides continuous cerebral function monitoring, will be used for aEEG recordings at four time points. After a minimum baseline aEEG tracing of 4 hours, a sensory intervention (that has no movement artifact) will be performed for one hour, followed by monitoring for one additional hour after the sensory intervention is removed. This will be a total monitoring time of 6 hours. We will record who performed the intervention (parent, volunteer, research member) and the type of intervention (ie. holding, kangaroo, reading). Scores will also be evaluated as an outcome measure across PMA
Time frame: within two weeks of birth, at 30 and 34 weeks PMA, and between 35-41 weeks PMA for six continuous hours
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