RecruitingNot ApplicableNCT05230199

Sensory Optimization of the Hospital Environment

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


Sponsor

University of Southern California

Enrollment

215 participants

Start Date

May 29, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 1 DayMax Age: 7 Days

Inclusion Criteria2

  • ≤ 32 weeks estimated gestational age (EGA)
  • recruited within the first week of life

Exclusion Criteria5

  • \> 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.

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Interventions

BEHAVIORALSENSE 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.

BEHAVIORALMonitored standard of care

Infants who receive sensory exposures only as standard of care but do not recieve the SENSE program


Locations(1)

Cardinal Glennon Children's Hospital

St Louis, Missouri, United States

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