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Multisensory Intervention for Premature Birth (SOOTHE Trial)

Q: Does this trial permit the inclusion of participants who are 40 years or older?

According to the specified inclusion criteria, participants must be between 1 day and 7 days old. There are currently 285 trials recruiting minors and 149 that cater to seniors.

Q: Are there certain demographics that are more likely to benefit from participation in this clinical study?

Qualifying newborns for this research must have been born prematurely and be between 1 day to 7 days old. The recruitment process is aiming to secure 215 participants in total.

Q: What is the uppermost cap on participants in this clinical experiment?

Affirmative. Clinicaltrials.gov shows that this clinical trial is actively recruiting participants, having been initially posted on April 1st 2023 and edited most recently on the 19th of April 2023. The study aims to enroll 215 patients at one particular site.

Q: Are there vacancies for participants in this experiment?

Affirmative, the information hosted on clinicaltrials.gov indicates that this trial is presently enlisting participants. The study was initially published on April 1st 2023 and updated most recently on April 19th 2023; it requires 215 individuals from a single site to be recruited.

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

SOOTHE Trial 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.

SOOTHE Trial 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.

SOOTHE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years adjusted age is primary outcome; also will be done at 1 year adjusted

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

SOOTHE 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.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor

906 Previous Clinical Trials

1,595,961 Total Patients Enrolled

St. Louis UniversityOTHER

194 Previous Clinical Trials

43,440 Total Patients Enrolled

Washington University School of MedicineOTHER

1,937 Previous Clinical Trials

2,299,480 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial permit the inclusion of participants who are 40 years or older?

"According to the specified inclusion criteria, participants must be between 1 day and 7 days old. There are currently 285 trials recruiting minors and 149 that cater to seniors."

Answered by AI

Are there certain demographics that are more likely to benefit from participation in this clinical study?

"Qualifying newborns for this research must have been born prematurely and be between 1 day to 7 days old. The recruitment process is aiming to secure 215 participants in total."

Answered by AI

What is the uppermost cap on participants in this clinical experiment?

"Affirmative. Clinicaltrials.gov shows that this clinical trial is actively recruiting participants, having been initially posted on April 1st 2023 and edited most recently on the 19th of April 2023. The study aims to enroll 215 patients at one particular site."

Answered by AI

Are there vacancies for participants in this experiment?

"Affirmative, the information hosted on clinicaltrials.gov indicates that this trial is presently enlisting participants. The study was initially published on April 1st 2023 and updated most recently on April 19th 2023; it requires 215 individuals from a single site to be recruited."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sensory Optimization of the Hospital Environment

Roberta Pineda 2023. "Sensory Optimization of the Hospital Environment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05230199.