← Back to Search

Multisensory Intervention for Premature Birth (SOOTHE Trial)

N/A
Recruiting
Led By Roberta Pineda, PhD OTR/L
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Recruited within the first week of life
≤ 32 weeks estimated gestational age (EGA)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years adjusted age is primary outcome; also will be done at 1 year adjusted
Awards & highlights

Summary

This trial aims to improve preemie health & parent well-being by providing multisensory interventions (massage, auditory exposure, rocking, etc.) to help with mental health, parent-child interaction, brain activity, & language development.

Who is the study for?
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.Check my eligibility
What is being tested?
The study tests a structured multisensory program called SENSE against standard care in the NICU. SENSE includes massage, auditory exposure, rocking, holding, and skin-to-skin care tailored to each infant's developmental stage and health status.See study design
What are the potential side effects?
As this intervention involves non-invasive sensory activities provided by parents under guidance in the NICU setting, no direct side effects are anticipated; however individual responses may vary based on each infant’s condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My baby is less than one week old.
Select...
I am less than or equal to 32 weeks pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years adjusted age is primary outcome; also will be done at 1 year adjusted
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years adjusted age is primary outcome; also will be done at 1 year adjusted for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bayley Scales of Infant Toddler Development, 4th Edition, language outcome
Secondary outcome measures
Ages and Stages Questionnaire-3
Bayley Scales of Infant Toddler Development, 4th Edition, cognitive outcome
Bayley Scales of Infant Toddler Development, 4th Edition, motor outcome
+9 more
Other outcome measures
Family Resilience Assessment Scale
Home Observation Measurement of the Environment

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SENSE multisensory programExperimental Treatment1 Intervention
The SENSE program includes the provision of specific types and amounts of evidence-based tactile, auditory, visual, vestibular/kinesthetic, and olfactory interventions to be conducted by parents with their preterm infants, with a specific amount defined for each day of hospitalization. The program changes across PMA and an infant's tolerance of the prescribed activities. A sensory support team can fill in the gaps in intervention for infants in the SENSE group when parents are not available. The parent education materials identify specific doses of sensory inputs at each PMA. Feasibility has been established, with provision of an average of 155 hours of sensory exposures across NICU hospitalization.
Group II: Monitored standard of careActive Control1 Intervention
At the study site, much like other contemporary NICUs, parents are encouraged to be present 24 hours per day, with significant variability in the amount, types and timing of parent engagement. Infant holding is supported, provided the infant can maintain physiological stability during handling. Parents can hold infants on mechanical ventilation, but holding is not encouraged during times when the infant is on oscillatory ventilation and/or when chest tubes are in place. Holding time may be restricted in infants <32 weeks due to temperature instability. Nurses and therapists foster parent participation through instruction on caregiving and developmentally appropriate interactions, but these are balanced with other priorities of care. With standard of care, there is no targeted and set amount of positive sensory exposure, and practices vary based on the comfort level of nurses, the medical team, and the parents.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for preterm birth, such as those studied in the SENSE trial, include massage, auditory exposure, rocking, holding, and skin-to-skin care. These interventions replicate the natural sensory experiences of the womb, crucial for neurological and developmental growth. Massage stimulates the nervous system and improves circulation, promoting growth and relaxation. Auditory exposure enhances auditory processing and bonding. Rocking and holding provide vestibular stimulation, important for balance and spatial orientation. Skin-to-skin care regulates the infant's temperature, heart rate, and breathing, while also promoting bonding and breastfeeding. These treatments collectively foster healthy development and strengthen the parent-child relationship, essential for preterm infants at higher risk for developmental delays and health complications.

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
919 Previous Clinical Trials
1,611,226 Total Patients Enrolled
St. Louis UniversityOTHER
194 Previous Clinical Trials
43,431 Total Patients Enrolled
Washington University School of MedicineOTHER
1,949 Previous Clinical Trials
2,307,343 Total Patients Enrolled

Media Library

SENSE multisensory program Clinical Trial Eligibility Overview. Trial Name: NCT05230199 — N/A
Preterm Birth Research Study Groups: Monitored standard of care, SENSE multisensory program
Preterm Birth Clinical Trial 2023: SENSE multisensory program Highlights & Side Effects. Trial Name: NCT05230199 — N/A
SENSE multisensory program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05230199 — N/A
~136 spots leftby Aug 2026