Sensory Optimization of the Hospital Environment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-7
SponsorUniversity of Southern California

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 volunteers

Qualifiers

≤ 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

Design model

Parallel

Treatments tested in this trial

  • SENSE multisensory program

    Behavioral

    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.

  • Monitored standard of care

    Behavioral

    Infants who receive sensory exposures only as standard of care but do not recieve the SENSE program

Treatment groups

215 Participants
are divided into 2 treatment groups
Group A: Monitored standard of careActive comparator 1 intervention
Group B: SENSE multisensory programExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Bayley 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

Secondary outcomes

1

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)
2

NICU Network Neurobehavioral Assessment Scale

Standardized neonatal neurobehavioral assessment

Time frame
Between 35-41 weeks PMA
3

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,
4

Modified Checklist for Autism in Toddlers

Parent report measure of sensory features

Time frame
2 years adjusted age

Other outcomes

1

Home Observation Measurement of the Environment

self report measure of the home environment

Time frame
At 6 months, one and two years adjusted age
2

Family Resilience Assessment Scale

self report measure of family resilience

Time frame
At 6 months, one and two years adjusted age
3

Experiences and Satisfaction During Preterm Birth

self report measure of parent experience in NICU

Time frame
Prior to the infant's discharge from the NICU (35-41 weeks PMA)
4

Parent Stress Scale

self report measure of parent stress

Time frame
Prior to the infant's discharge from the NICU (35-41 weeks PMA)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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