Sensory Optimization of the Hospital Environment

Not Applicable

Recruiting

• Conditions: Parents; Development, Infant; Preterm; Sensory Integration Dysfunction; Parent-Child Relations

• 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.

Study Timeline

• Study First Submitted: 2022-01-27
• Study First Submitted QC: 2022-01-27
• Study First Posted: 2022-02-08
• Study Start: 2023-05-29
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-07
• Primary Completion: 2027-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 215

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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
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
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

Trial Locations

Locations (1)

Cardinal Glennon Children's Hospital; 🇺🇸 Saint Louis, Missouri, United States