Sensory Optimization of the Hospital Environment (SOOTHE)

June 15, 2026 updated by: Roberta Pineda, University of Southern California

Multisensory Interventions to Improve Neurodevelopmental Outcomes of Preterm Infants Hospitalized in the Neonatal Intensive Care Unit

The long-term goal of this project is to improve the health and well-being of preterm infants and their parents. Although there is evidence to support positive multisensory interventions in the NICU, these interventions are often applied in an inconsistent manner, reducing their benefit. Through a rigorous and scientific process, we have developed a structured multisensory intervention program, titled Supporting and Enhancing NICU Sensory Experiences (SENSE), which includes specific doses and targeted timing of evidence-based interventions such as massage, auditory exposure, rocking, holding, and skin-to-skin care. The interventions are based on the infant's developmental stage and are adapted based on the infant's medical status and behavioral cues. The multisensory interventions are designed to be conducted during each day of NICU hospitalization by the parents, who are educated and supported to provide them. The proposed work aims to determine the effect of multisensory interventions on parent mental health, parent-child interaction, brain activity (amplitude integrated electroencephalography), and infant developmental outcomes through age 2 years, with specific attention to language outcome.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Two-hundred fifteen parent-infant dyads of preterm infants born ≤ 32 weeks gestation and admitted to a Level IV NICU (and associated Level III NICU) will be enrolled within 1 week of birth. Infants will be randomized to either the SENSE multisensory program or to the standard of care during the NICU stay. The SENSE program combines structured, easy-to-conduct, multisensory interventions with parent engagement to optimize outcomes in the complex medical environment of the NICU. Standardized assessments of parent mental health, infant neurodevelopment, and parent-child interaction will be conducted prior to NICU discharge and at 6 months, 1 year, and 2 years, adjusted for prematurity. Differences between groups will be investigated. Brain activity during NICU stay, including in the presence and absence of different sensory exposures, will also be investigated. The expected outcome is that the SENSE multisensory program will have a positive effect on improving outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
215

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63104
        • Recruiting
        • Cardinal Glennon Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 day to 1 week (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Monitored standard of care
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.
Behavioral: Monitored standard of care
Infants who receive sensory exposures only as standard of care but do not recieve the SENSE program
Experimental: SENSE multisensory program
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.
Behavioral: SENSE multisensory program
In order to support parent's ability to implement the daily SENSE program they will be provided with an educational manual reviewing the program, weekly meetings with a therapist, and logs to report their visitation schedule and activities. Parents are able to choose different types of each sensory exposure. All options address the same key principles for that behavior and only include those that have evidence to support their use and are appropriate at each PMA.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Bayley Scales of Infant Toddler Development, 4th Edition
Time Frame: 2 years adjusted age
Standardized assessment of language, cognitive, and motor: language outcome is the primary outcome
2 years adjusted age

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
NICU Network Neurobehavioral Assessment Scale
Time Frame: Between 35-41 weeks PMA
Standardized neonatal neurobehavioral assessment
Between 35-41 weeks PMA
Sensory Profile 2
Time Frame: Prior to NICU discharge and at 6 months, 1 and 2 years adjusted age,
Parent-report measure of sensory processing
Prior to NICU discharge and at 6 months, 1 and 2 years adjusted age,
Modified Checklist for Autism in Toddlers
Time Frame: 2 years adjusted age
Parent report measure of sensory features
2 years adjusted age
Child Behavior Checklist (CBCL)
Time Frame: 2 years adjusted
Parent report measure of social emotional function
2 years adjusted
State Trait Anxiety Inventory
Time Frame: Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 6 months, one and 2 years adjusted age
Self report measure of anxiety
Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 6 months, one and 2 years adjusted age
Life Stress Subscale of the Parenting Stress Index (PSI)
Time Frame: Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 6 months, one and 2 years adjusted age
Self report measure of stress
Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 6 months, one and 2 years adjusted age
aEEG Burdjalov Score
Time Frame: within two weeks of birth, at 30 and 34 weeks PMA, and between 35-41 weeks PMA for six continuous hours
The Olympic Brainz Monitor (OBM) Monitor (TMNatus), which provides continuous cerebral function monitoring, will be used for aEEG recordings at four time points. After a minimum baseline aEEG tracing of 4 hours, a sensory intervention (that has no movement artifact) will be performed for one hour, followed by monitoring for one additional hour after the sensory intervention is removed. This will be a total monitoring time of 6 hours. We will record who performed the intervention (parent, volunteer, research member) and the type of intervention (ie. holding, kangaroo, reading). Scores will also be evaluated as an outcome measure across PMA
within two weeks of birth, at 30 and 34 weeks PMA, and between 35-41 weeks PMA for six continuous hours
Bayley Scales of Infant Toddler Development, 4th Edition
Time Frame: 6 months and 1 year adjusted age (when completed in newborn follow-up clinic)
Standardized assessment of language, cognitive, and motor
6 months and 1 year adjusted age (when completed in newborn follow-up clinic)
Ages and Stages Questionnaire-3
Time Frame: 6 months adjusted age, 1 and 2 years adjusted age
parent report measure of development
6 months adjusted age, 1 and 2 years adjusted age
Emotional Availability Scales
Time Frame: Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 2 years adjusted
Standardized observational assessment of parent-child interaction
Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 2 years adjusted
Edinburgh Postnatal Depression Scale (EPDS)
Time Frame: Prior to the infant's discharge from the NICU (35-41 weeks PMA)
Self report measure of maternal postpartum depression
Prior to the infant's discharge from the NICU (35-41 weeks PMA)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Home Observation Measurement of the Environment
Time Frame: At 6 months, one and two years adjusted age
self report measure of the home environment
At 6 months, one and two years adjusted age
Family Resilience Assessment Scale
Time Frame: At 6 months, one and two years adjusted age
self report measure of family resilience
At 6 months, one and two years adjusted age
Experiences and Satisfaction During Preterm Birth
Time Frame: Prior to the infant's discharge from the NICU (35-41 weeks PMA)
self report measure of parent experience in NICU
Prior to the infant's discharge from the NICU (35-41 weeks PMA)
Parent Stress Scale
Time Frame: Prior to the infant's discharge from the NICU (35-41 weeks PMA)
self report measure of parent stress
Prior to the infant's discharge from the NICU (35-41 weeks PMA)
Parent Stress Scale: NICU
Time Frame: Prior to the infant's discharge from the NICU (35-41 weeks PMA)
Self report measure of parent stress related to NICU hospitalization
Prior to the infant's discharge from the NICU (35-41 weeks PMA)
Maternal Confidence Questionnaire
Time Frame: Prior to the infant's discharge from the NICU (35-41 weeks PMA)
Self report measure of parental confidence related to care of infant
Prior to the infant's discharge from the NICU (35-41 weeks PMA)
Infant Care Questionnaire
Time Frame: Prior to the infant's discharge from the NICU (35-41 weeks PMA)
Self report measure of parental confidence related to care of infant
Prior to the infant's discharge from the NICU (35-41 weeks PMA)
Parent Stress Inventory
Time Frame: Prior to the infant's discharge from the NICU (35-41 weeks PMA), 6 months adjusted age
Self report measure of parent stress
Prior to the infant's discharge from the NICU (35-41 weeks PMA), 6 months adjusted age
Parenting Sense of Competence
Time Frame: Prior to the infant's discharge from the NICU (35-41 weeks PMA), 6 months adjusted age, 1 year adjusted age, 2 years adjusted age
Self report measure of parent feelings of competence related to care of infant
Prior to the infant's discharge from the NICU (35-41 weeks PMA), 6 months adjusted age, 1 year adjusted age, 2 years adjusted age
Neonatal Eating Outcome Assessment Tool
Time Frame: Prior to the infant's discharge from the NICU (35-41 weeks PMA)
Assessment of infant feeding skills
Prior to the infant's discharge from the NICU (35-41 weeks PMA)
Post Traumatic Stress Disorder Questionnaire
Time Frame: 6 months adjusted age, 1 year adjusted age
Assessment of parental PTSD
6 months adjusted age, 1 year adjusted age
Sleep and Settle Questionnaire
Time Frame: 6 months adjusted age, 1 year adjusted age
Assessment of infant sleep patterns
6 months adjusted age, 1 year adjusted age
General Anxiety Disorder 7 Scale
Time Frame: 6 months adjusted age
Assessment of parental anxiety
6 months adjusted age
Beck Depression Inventory II
Time Frame: 6 months adjusted age, 1 year adjusted age, 2 years adjusted age
Assessment of parental depression
6 months adjusted age, 1 year adjusted age, 2 years adjusted age
Pediatric Eating Assessment Tool
Time Frame: 1 year adjusted age, 2 years adjusted age
Assessment of child feeding skills
1 year adjusted age, 2 years adjusted age
Behavioral Pediatric Feeding Assessment Scale
Time Frame: 1 year adjusted age, 2 years adjusted age
Assessment of child feeding behaviors
1 year adjusted age, 2 years adjusted age
NEO-Eat
Time Frame: 6 months adjusted age
Parent report measure of feeding during infancy
6 months adjusted age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Southern California

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Washington University School of Medicine
Harvard University
St. Louis Children's Hospital
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
St. Louis University
University of North Carolina

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Roberta Pineda, PhD OTR/L, University of Southern California
  • Principal Investigator: Amit Mathur, MD, St. Louis University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 29, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01HD105557 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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