Sensory Optimization of the Hospital Environment

Part of paid clinical trials in St Louis, Missouri.

Sponsor
University of Southern California
Study ID
NCT05230199
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
1 Day - 7 Days
Healthy Volunteers
Not accepted

Interventions

  • SENSE multisensory program — BEHAVIORAL
    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.
  • Monitored standard of care — BEHAVIORAL
    Infants who receive sensory exposures only as standard of care but do not recieve the SENSE program

Study Details

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.

Key Dates

Start date
May 29, 2023
Status verified
Aug 2024
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
215 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Monitored standard of care
    At the study site, much like other contemporary NICUs, parents are encouraged to be present 24 hours per day, with significant variability in the amount, types and timing of parent engagement. Infant holding is supported, provided the infant can maintain physiological stability during handling. Parents can hold infants on mechanical ventilation, but holding is not encouraged during times when the infant is on oscillatory ventilation and/or when chest tubes are in place. Holding time may be restricted in infants \<32 weeks due to temperature instability. Nurses and therapists foster parent participation through instruction on caregiving and developmentally appropriate interactions, but these are balanced with other priorities of care. With standard of care, there is no targeted and set amount of positive sensory exposure, and practices vary based on the comfort level of nurses, the medical team, and the parents.
  • Experimental: SENSE multisensory program
    The SENSE program includes the provision of specific types and amounts of evidence-based tactile, auditory, visual, vestibular/kinesthetic, and olfactory interventions to be conducted by parents with their preterm infants, with a specific amount defined for each day of hospitalization. The program changes across PMA and an infant's tolerance of the prescribed activities. A sensory support team can fill in the gaps in intervention for infants in the SENSE group when parents are not available. The parent education materials identify specific doses of sensory inputs at each PMA. Feasibility has been established, with provision of an average of 155 hours of sensory exposures across NICU hospitalization.

Primary Outcome Measure

Bayley Scales of Infant Toddler Development, 4th Edition [ Time Frame: 2 years adjusted age ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cardinal Glennon Children's HospitalSt LouisMissouri63104
Amit Mathur, MD, PhD
[email protected]
314-577-5360

Find similar trials in St Louis, MO

By research site
Cardinal Glennon Children's Hospital· St Louis, MO

Related Studies