About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≤ 32 weeks estimated gestational age (EGA)
recruited within the first week of life
Disqualifiers
> 32 weeks EGA at birth
>7 days old
become wards of the state
have a suspected or confirmed congenital anomaly
Trial design
Parallel
Treatments tested in this trial
SENSE multisensory program
BehavioralIn 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.
Monitored standard of care
BehavioralInfants who receive sensory exposures only as standard of care but do not recieve the SENSE program
Treatment groups
Trial outcomes
Primary outcomes
Bayley Scales of Infant Toddler Development, 4th Edition
Standardized assessment of language, cognitive, and motor: language outcome is the primary outcome
Secondary outcomes
Bayley Scales of Infant Toddler Development, 4th Edition
Standardized assessment of language, cognitive, and motor
NICU Network Neurobehavioral Assessment Scale
Standardized neonatal neurobehavioral assessment
Sensory Profile 2
Parent-report measure of sensory processing
Modified Checklist for Autism in Toddlers
Parent report measure of sensory features
Other outcomes
Home Observation Measurement of the Environment
self report measure of the home environment
Family Resilience Assessment Scale
self report measure of family resilience
Experiences and Satisfaction During Preterm Birth
self report measure of parent experience in NICU
Parent Stress Scale
self report measure of parent stress
Sponsors and contacts
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University of Southern California
Lead sponsor
St. Louis University
Collaborator
Washington University School of Medicine
Collaborator
University of North Carolina
Collaborator
Harvard University
Collaborator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborator
St. Louis Children's Hospital
Collaborator