Sensory Optimization of the Hospital Environment

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.

Conditions

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

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

Sponsors & Collaborators

• St. Louis University

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• University of North Carolina

  collaborator OTHER

• Harvard University

  collaborator OTHER

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

  collaborator OTHER

• St. Louis Children's Hospital

  collaborator OTHER

• University of Southern California

  lead OTHER

Principal Investigators

• Roberta Pineda, PhD OTR/L · University of Southern California

• Amit Mathur, MD · St. Louis University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

7 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-29

Primary Completion

2027-08-31

Completion

2027-08-31

Countries

• United States

Study Locations