Sensory Optimization of the Hospital Environment

Last updated: August 1, 2024
Sponsor: University of Southern California
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

SENSE multisensory program

Monitored standard of care

Clinical Study ID

NCT05230199
R01HD105557
  • Ages 1-7
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≤ 32 weeks estimated gestational age (EGA)

  • recruited within the first week of life

Exclusion

Exclusion Criteria:

  • > 32 weeks EGA at birth

  • >7 days old

  • become wards of the state

  • have a suspected or confirmed congenital anomaly

  • face a high immediate threat of death, per the opinion of the attending physician.

Study Design

Total Participants: 215
Treatment Group(s): 2
Primary Treatment: SENSE multisensory program
Phase:
Study Start date:
May 29, 2023
Estimated Completion Date:
August 31, 2027

Study Description

Two-hundred fifteen parent-infant dyads of preterm infants born ≤ 32 weeks gestation and admitted to a Level IV NICU (and associated Level III 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.

Connect with a study center

  • Cardinal Glennon Children's Hospital

    Saint Louis, Missouri 63104
    United States

    Active - Recruiting

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