NCT05230199 Sensory Optimization of the Hospital Environment
| NCT ID | NCT05230199 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Southern California |
| Condition | Preterm |
| Study Type | INTERVENTIONAL |
| Enrollment | 215 participants |
| Start Date | 2023-05-29 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 215 participants in total. It began in 2023-05-29 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria: * ≤ 32 weeks estimated gestational age (EGA) * recruited within the first week of life 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.
Contact & Investigator
Roberta Pineda, PhD OTR/L
PRINCIPAL INVESTIGATOR
University of Southern California
Frequently Asked Questions
Who can join the NCT05230199 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 7 Days, studying Preterm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05230199 currently recruiting?
Yes, NCT05230199 is actively recruiting participants. Contact the research team at bobbi.pineda@chan.usc.edu for enrollment information.
Where is the NCT05230199 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT05230199 clinical trial?
NCT05230199 is sponsored by University of Southern California. The principal investigator is Roberta Pineda, PhD OTR/L at University of Southern California. The trial plans to enroll 215 participants.