Sensory Optimization of the Hospital Environment — SOOTHE  

Parent-Child Relations Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Two-hundred fifteen parent-infant dyads of preterm infants born ≤ 32 weeks gestation and admitted to a Level IV NICU will be enrolled within 1 week of birth. Infants will be randomized to either the SENSE multisensory program or to the standard of care during the NICU stay. The SENSE program combines structured, easy-to-conduct, multisensory interventions with parent engagement to optimize outcomes in the complex medical environment of the NICU. Standardized assessments of parent mental health, infant neurodevelopment, and parent-child interaction will be conducted prior to NICU discharge and at 6 months, 1 year, and 2 years, adjusted for prematurity. Differences between groups will be investigated. Brain activity during NICU stay, including in the presence and absence of different sensory exposures, will also be investigated. The expected outcome is that the SENSE multisensory program will have a positive effect on improving outcomes. ;

Related Conditions & MeSH terms

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

• NCT number: NCT05230199
• Study type: Interventional
• Source: University of Southern California
• Contact: Roberta Pineda, PhD OTR/L
• Phone: (323) 442-2850
• Email: bobbi.pineda@chan.usc.edu
• Status: Recruiting
• Phase: N/A
• Start date: May 29, 2023
• Completion date: March 2027