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.

NCT05230199

Sensory Optimization of the Hospital Environment

Recruiting
NAAges 1–7InterventionalTreatment
University of Southern California
~215 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:SENSE multisensory programMonitored standard of care

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Bayley Scales of Infant Toddler Development, 4th Edition
Measured over 2 years adjusted age
Preterm
Parent-Child Relations
Parents
Development, Infant
Sensory Integration Dysfunction

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.

  • Roberta Pineda, PhD OTR/L · PRINCIPAL_INVESTIGATOR · University of Southern California
  • Amit Mathur, MD · PRINCIPAL_INVESTIGATOR · St. Louis University

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Eligibility criteria

Inclusion

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

Exclusion

\> 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.
  • Bayley Scales of Infant Toddler Development, 4th Edition2 years adjusted age

    Standardized assessment of language, cognitive, and motor: language outcome is the primary outcome