Sensory Optimization for Preterm Infants in the NICU
This study is looking at ways to improve the health and well-being of preterm infants and their parents. It tests a program called SENSE (Supporting and Enhancing NICU Sensory Experiences), which involves structured activities like massage, rocking, and skin-to-skin care, tailored to your baby's development. You and your baby would either receive the SENSE program with support from a therapist, or standard care. Researchers want to see if the SENSE program helps improve your baby's development and your mental health as a parent. We are looking for 215 parent-infant pairs where the baby was born at 32 weeks or less and is 1 to 7 days old. The study is currently unclear on its recruitment status.
- Study design
- This study will include 215 parent-infant pairs. Infants will be randomly assigned to either the SENSE multisensory program or standard care.
- What's involved
- If you participate, you would engage in the SENSE program with your baby, supported by an educational manual, weekly therapist meetings, and activity logs. Your baby's development, your mental health, and your interaction with your baby will be assessed before discharge and at 6 months, 1 year, and 2 years after your baby's adjusted age.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed until their child is 2 years old (adjusted for prematurity).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Sensory Optimization of the Hospital Environment
At a glance
Conditions
NCT05230199
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Cardinal Glennon Children's Hospital
St Louis, Missouristudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Roberta Pineda, PhD OTR/L · PRINCIPAL_INVESTIGATOR · University of Southern California
- Amit Mathur, MD · PRINCIPAL_INVESTIGATOR · St. Louis University
Who to contact
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Inclusion
Exclusion
What this trial measures
- Bayley Scales of Infant Toddler Development, 4th Edition2 years adjusted age
Standardized assessment of language, cognitive, and motor: language outcome is the primary outcome