Development, Infant, Parent-Child Relations, Parents, Preterm, Sensory Integration Dysfunction
Conditions
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.
Interventions
BEHAVIORALSENSE multisensory program
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.
BEHAVIORALMonitored standard of care
Infants who receive sensory exposures only as standard of care but do not recieve the SENSE program
Sponsors
University of Southern California
St. Louis University
Washington University School of Medicine
University of North Carolina
Harvard University
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
St. Louis Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Parents will enroll in this study, understanding that they will be assigned to one of two types of sensory approaches. They will be masked from whether they are in the treatment (SENSE group) or control group (standard of care). After enrollment, the SENSE program will be described to those parents assigned to the SENSE group. The use of nurses and therapists to aid the parent in conducting sensory interventions at the bedside will be described to those parents assigned to the standard of care group. All assessments in the NICU will be conducted at the infant's bedside by a certified (when necessary) and trained evaluator who is blinded to treatment assignment. All assessments following NICU discharge will be conducted by a different blinded evaluator (to decrease bias), who is trained and experienced with standardized childhood assessment. The evaluators will not be involved in other study-related activities in order to maintain blinding.
Eligibility
Sex/Gender
ALL
Age
1 Days to 7 Days
Healthy volunteers
No
Inclusion criteria
* ≤ 32 weeks estimated gestational age (EGA) * recruited within the first week of life
Exclusion criteria
* \> 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| NICU Network Neurobehavioral Assessment Scale | Between 35-41 weeks PMA | Standardized neonatal neurobehavioral assessment |
| Sensory Profile 2 | Prior to NICU discharge and at 6 months, 1 and 2 years adjusted age, | Parent-report measure of sensory processing |
| Modified Checklist for Autism in Toddlers | 2 years adjusted age | Parent report measure of sensory features |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
United States
Contacts
CONTACTRoberta Pineda, PhD OTR/L
CONTACTAmit Mathur, MD
PRINCIPAL_INVESTIGATORRoberta Pineda, PhD OTR/L
University of Southern California
PRINCIPAL_INVESTIGATORAmit Mathur, MD
St. Louis University
Outcome results
None listed