Actively Recruiting

Phase Not Applicable
Age: 1Day - 7Days
All Genders
NCT05230199

Sensory Optimization of the Hospital Environment

Led by University of Southern California · Updated on 2024-08-07

215

Participants Needed

1

Research Sites

222 weeks

Total Duration

On this page

Sponsors

U

University of Southern California

Lead Sponsor

S

St. Louis University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Sensory Optimization of the Hospital Environment

Who Can Participate

Age: 1Day - 7Days
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Born at or before 32 weeks estimated gestational age
  • Enrolled within the first week of life
Not Eligible

You will not qualify if you...

  • Born after 32 weeks estimated gestational age
  • Older than 7 days at enrollment
  • Are wards of the state
  • Have suspected or confirmed congenital anomalies
  • Are considered at high immediate risk of death by their doctor

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Cardinal Glennon Children's Hospital

St Louis, Missouri, United States, 63104

Actively Recruiting

Loading map...

Research Team

R

Roberta Pineda, PhD OTR/L

CONTACT

A

Amit Mathur, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here