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

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

Treatments tested in this trial

  • SENSE multisensory program
  • Monitored standard of care

Treatment groups

215 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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