Actively Recruiting
Multisensory Interventions to Improve Neurodevelopmental Outcomes of Preterm Infants Hospitalized in the Neonatal Intensive Care Unit
Led by University of Southern California · Updated on 2024-08-07
215
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Southern California
Lead Sponsor
S
St. Louis University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of a structured multisensory intervention program called Supporting and Enhancing NICU Sensory Experiences (SENSE) on preterm infants born at or before 32 weeks gestation and their parents. The goal is to improve infant developmental outcomes, parent mental health, and parent-child interactions during and after Neonatal Intensive Care Unit (NICU) hospitalization. This interventional study compares the SENSE program to standard care in a randomized design. The SENSE program provides parents with specific, evidence-based multisensory activities such as massage, auditory exposure, rocking, holding, and skin-to-skin care. These activities are tailored to the infant's developmental stage and medical condition with daily doses during the NICU stay. Parents receive education, weekly therapist meetings, and logs to support participation. A sensory support team assists when parents are unavailable. The comparison group receives usual NICU care without a structured sensory program. Participants will be assessed before NICU discharge and at 6 months, 1 year, and 2 years adjusted age using standardized tests for infant development, brain activity, parent mental health, and parent-child interaction. Brain activity will be monitored using amplitude integrated electroencephalography (aEEG) during the NICU stay. Researchers will measure outcomes including the Bayley Scales of Infant Toddler Development at 2 years adjusted age. The total follow-up lasts until the child reaches 2 years adjusted age.
CONDITIONS
Brief Title
Sensory Optimization of the Hospital Environment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infant born at or before 32 weeks estimated gestational age
- Recruited within the first week of life
You will not qualify if you...
- Infant born after 32 weeks estimated gestational age
- Infant older than 7 days at recruitment
- Infant is a ward of the state
- Infant has a suspected or confirmed congenital anomaly
- Infant faces a high immediate threat of death as assessed by a physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Within 1 week of birth
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of NICU stay
Participants receive either the SENSE multisensory program or standard sensory care during the NICU stay, with parent engagement and multisensory interventions tailored to the infant's postmenstrual age and tolerance.
Daily interventions and weekly meetings with a therapist for parents in the SENSE program
Duration - Up to 2 years adjusted age
Standardized assessments of infant neurodevelopment, parent mental health, and parent-child interaction are conducted prior to NICU discharge and at 6 months, 1 year, and 2 years adjusted age.
Assessments at NICU discharge, 6 months, 1 year, and 2 years (in-person visits)
Trial Site Locations
Total: 1 location
1
Cardinal Glennon Children's Hospital
St Louis, Missouri, United States, 63104
Actively Recruiting
Research Team
R
Roberta Pineda, PhD OTR/L
A
Amit Mathur, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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