Sensory Optimization of the Hospital Environment
- Conditions
- ParentsDevelopment, InfantPretermSensory Integration DysfunctionParent-Child Relations
- Interventions
- Behavioral: Monitored standard of careBehavioral: SENSE multisensory program
- Registration Number
- NCT05230199
- Lead Sponsor
- University of Southern California
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 215
- ≤ 32 weeks estimated gestational age (EGA)
- recruited within the first week of life
- > 32 weeks EGA at birth
- >7 days old
- become wards of the state
- have a suspected or confirmed congenital anomaly
- face a high immediate threat of death, per the opinion of the attending physician.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Monitored standard of care Monitored standard of care At the study site, much like other contemporary NICUs, parents are encouraged to be present 24 hours per day, with significant variability in the amount, types and timing of parent engagement. Infant holding is supported, provided the infant can maintain physiological stability during handling. Parents can hold infants on mechanical ventilation, but holding is not encouraged during times when the infant is on oscillatory ventilation and/or when chest tubes are in place. Holding time may be restricted in infants \<32 weeks due to temperature instability. Nurses and therapists foster parent participation through instruction on caregiving and developmentally appropriate interactions, but these are balanced with other priorities of care. With standard of care, there is no targeted and set amount of positive sensory exposure, and practices vary based on the comfort level of nurses, the medical team, and the parents. SENSE multisensory program SENSE multisensory program The SENSE program includes the provision of specific types and amounts of evidence-based tactile, auditory, visual, vestibular/kinesthetic, and olfactory interventions to be conducted by parents with their preterm infants, with a specific amount defined for each day of hospitalization. The program changes across PMA and an infant's tolerance of the prescribed activities. A sensory support team can fill in the gaps in intervention for infants in the SENSE group when parents are not available. The parent education materials identify specific doses of sensory inputs at each PMA. Feasibility has been established, with provision of an average of 155 hours of sensory exposures across NICU hospitalization.
- Primary Outcome Measures
Name Time Method Bayley Scales of Infant Toddler Development, 4th Edition 2 years adjusted age Standardized assessment of language, cognitive, and motor: language outcome is the primary outcome
- Secondary Outcome Measures
Name Time Method Sensory Profile 2 Prior to NICU discharge and at 6 months, 1 and 2 years adjusted age, Parent-report measure of sensory processing
State Trait Anxiety Inventory Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 6 months, one and 2 years adjusted age Self report measure of anxiety
Bayley Scales of Infant Toddler Development, 4th Edition 6 months and 1 year adjusted age (when completed in newborn follow-up clinic) Standardized assessment of language, cognitive, and motor
Modified Checklist for Autism in Toddlers 2 years adjusted age Parent report measure of sensory features
NICU Network Neurobehavioral Assessment Scale Between 35-41 weeks PMA Standardized neonatal neurobehavioral assessment
aEEG Burdjalov Score within two weeks of birth, at 30 and 34 weeks PMA, and between 35-41 weeks PMA for six continuous hours 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
Life Stress Subscale of the Parenting Stress Index (PSI) Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 6 months, one and 2 years adjusted age Self report measure of stress
Ages and Stages Questionnaire-3 6 months adjusted age, 1 and 2 years adjusted age parent report measure of development
Child Behavior Checklist (CBCL) 2 years adjusted Parent report measure of social emotional function
Edinburgh Postnatal Depression Scale (EPDS) Prior to the infant's discharge from the NICU (35-41 weeks PMA) Self report measure of maternal postpartum depression
Emotional Availability Scales Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 2 years adjusted Standardized observational assessment of parent-child interaction
Trial Locations
- Locations (1)
Cardinal Glennon Children's Hospital
🇺🇸Saint Louis, Missouri, United States