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RECRUITING
NCT05230199
NA

Sensory Optimization of the Hospital Environment

Sponsor: University of Southern California

View on ClinicalTrials.gov

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.

Official title: Multisensory Interventions to Improve Neurodevelopmental Outcomes of Preterm Infants Hospitalized in the Neonatal Intensive Care Unit

Key Details

Gender

All

Age Range

1 Day - 7 Days

Study Type

INTERVENTIONAL

Enrollment

215

Start Date

2023-05-29

Completion Date

2027-08-31

Last Updated

2024-08-07

Healthy Volunteers

No

Interventions

BEHAVIORAL

SENSE 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.

BEHAVIORAL

Monitored standard of care

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

Locations (1)

Cardinal Glennon Children's Hospital

St Louis, Missouri, United States