Multisensory Intervention for Premature Birth
(SOOTHE Trial)
Trial Summary
What is the purpose of this trial?
This trial aims to help preterm babies and their parents by using a structured program called SENSE. The program includes activities like massage and skin-to-skin contact that parents can do regularly. These activities are designed to support the baby's development and improve parent-child bonding. The SENSE program is a structured sensory-based program developed to maximize the benefit of parent-directed, positive sensory exposures in the NICU.
Do I need to stop my current medications for the trial?
The trial information does not specify whether participants need to stop taking their current medications.
What data supports the effectiveness of the treatment Multisensory Intervention for Premature Birth?
Research shows that the SENSE program, which is part of the multisensory intervention, helps improve infant development and reduces parent stress by providing positive sensory experiences like music and touch for preterm infants in the NICU. Studies have found that these sensory exposures are beneficial for the development of high-risk infants.12345
Is the multisensory intervention for premature birth safe for humans?
The SENSE program, which is a multisensory intervention for preterm infants, has been reviewed and updated based on evidence and stakeholder input to ensure it is safe and developmentally appropriate. The program is designed to provide positive sensory experiences in the NICU, and no safety concerns have been reported in the available research.12356
How is the SENSE multisensory program different from other treatments for premature birth?
The SENSE multisensory program is unique because it involves parents in providing a structured, multisensory experience for their preterm infants, which can improve language and motor skills development. Unlike other treatments that may focus on single sensory inputs, this program uses a combination of sensory experiences to support the infant's development and reduce parental stress.12578
Research Team
Amit Mathur, MD
Principal Investigator
St. Louis University
Roberta Pineda, PhD OTR/L
Principal Investigator
University of Southern California
Eligibility Criteria
This trial is for infants born prematurely (≤32 weeks gestational age) and within their first week of life. It's not suitable for those older than 7 days, with a high risk of immediate death, wards of the state, or suspected congenital anomalies.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
NICU Stay
Infants receive either the SENSE multisensory program or standard care during their NICU hospitalization
Follow-up
Participants are monitored for developmental outcomes and parent-child interactions at various intervals
Treatment Details
Interventions
- Monitored standard of care (Behavioural Intervention)
- SENSE multisensory program (Behavioural Intervention)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Southern California
Lead Sponsor
St. Louis University
Collaborator
Washington University School of Medicine
Collaborator
University of North Carolina
Collaborator
Harvard University
Collaborator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborator
St. Louis Children's Hospital
Collaborator