Improving the hospital environment for preterm infants and their parents
Official title: Multisensory Interventions to Improve Neurodevelopmental Outcomes of Preterm Infants Hospitalized in the Neonatal Intensive Care Unit
Run by University of Southern California · NCT05230199 · Data updated 2026-11-12
This study is testing a special program to see if it helps preterm infants and their parents feel better and bond more during their time in the NICU compared to regular care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Day to 7 Days |
| Sex | All |
| Enrollment | 215 (estimated) |
| Sponsor | University of Southern California Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Status | Recruiting |
| Started | May 29, 2023 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | June 17, 2026 |
| Trial ID | NCT05230199 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are preterm infants born at or before 32 weeks gestation, along with their parents, who can participate within the first week of life.
✕Probably not a fit
Patients who are more than 32 weeks gestational age at birth or older than 7 days at the time of recruitment will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project aims to enhance the health and well-being of preterm infants and their parents through a structured multisensory intervention program called Supporting and Enhancing NICU Sensory Experiences (SENSE). The program includes specific doses and timing of interventions such as massage, auditory exposure, rocking, holding, and skin-to-skin care, tailored to the infant's developmental stage and medical status. Two-hundred fifteen parent-infant dyads will be enrolled within the first week of life and randomized to either the SENSE program or standard care during their NICU stay. Assessments of parent mental health, infant neurodevelopment, and parent-child interaction will be conducted at various intervals to evaluate the program's effectiveness.
Why it matters
Potential benefit: If successful, this program could significantly improve developmental outcomes for preterm infants and strengthen parent-child relationships.
How similar studies have gone: Previous studies have shown positive outcomes with multisensory interventions in NICUs, suggesting that this approach is promising and builds on established evidence.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Cardinal Glennon Children's Hospital
St Louis, Missouri, United States Recruiting
Study contacts
- Principal investigator: Roberta Pineda, PhD OTR/L — University of Southern California
- Study coordinator: Roberta Pineda, PhD OTR/L
- Email: bobbi.pineda@chan.usc.edu
- Phone: (323) 442-2850
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.