PretermSOOTHENCT05230199
Sensory Optimization of the Hospital Environment
A study testing SENSE multisensory program in people with Preterm and Parent-Child Relations, run by University of Southern California at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 day to 7 days
- Conditions the study is for
- Preterm, Parent-Child Relations, Parents
- What is being tested?
- SENSE multisensory program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2023to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ≤ 32 weeks estimated gestational age (EGA)
- recruited within the first week of life
Who cannot join
- > 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cardinal Glennon Children's Hospital
St Louis, Missouri, 63104
Amit Mathur, MD, PhD, (314) 577-5360, amit.mathur@health.slu.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Preterm, Parent-Child Relations, Parents, Development, Infant, Sensory Integration Dysfunction
- Being tested
- SENSE multisensory program, Monitored standard of care
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENSE multisensory programBehavioural
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.
Monitored standard of careBehavioural
Infants who receive sensory exposures only as standard of care but do not recieve the SENSE program
| Study group | Role | What they receive |
|---|---|---|
| Monitored standard of care | Active comparator | 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. Receives: Behavioral: Monitored standard of care |
| SENSE multisensory program | Experimental | 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. Receives: Behavioral: SENSE multisensory program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bayley Scales of Infant Toddler Development, 4th Edition
Standardized assessment of language, cognitive, and motor: language outcome is the primary outcome
Measured: 2 years adjusted age
Secondary outcomes (11)
Bayley Scales of Infant Toddler Development, 4th Edition
Standardized assessment of language, cognitive, and motor
Measured: 6 months and 1 year adjusted age (when completed in newborn follow-up clinic)
NICU Network Neurobehavioral Assessment Scale
Standardized neonatal neurobehavioral assessment
Measured: Between 35-41 weeks PMA
Sensory Profile 2
Parent-report measure of sensory processing
Measured: Prior to NICU discharge and at 6 months, 1 and 2 years adjusted age,
Modified Checklist for Autism in Toddlers
Parent report measure of sensory features
Measured: 2 years adjusted age
Ages and Stages Questionnaire-3
parent report measure of development
Measured: 6 months adjusted age, 1 and 2 years adjusted age
Child Behavior Checklist (CBCL)
Parent report measure of social emotional function
Measured: 2 years adjusted
Emotional Availability Scales
Standardized observational assessment of parent-child interaction
Measured: Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 2 years adjusted
State Trait Anxiety Inventory
Self report measure of anxiety
Measured: 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)
Self report measure of stress
Measured: Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 6 months, one and 2 years adjusted age
Edinburgh Postnatal Depression Scale (EPDS)
Self report measure of maternal postpartum depression
Measured: Prior to the infant's discharge from the NICU (35-41 weeks PMA)
aEEG Burdjalov Score
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
Measured: within two weeks of birth, at 30 and 34 weeks PMA, and between 35-41 weeks PMA for six continuous hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start29 May 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 215 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- St. Louis University, Washington University School of Medicine, University of North Carolina, Harvard University, Hugo W. Moser Research Institute at Kennedy Krieger, Inc., St. Louis Children's Hospital
- Responsible party
- Principal investigator, Roberta Pineda, University of Southern California
- Investigators
- Roberta Pineda, PhD OTR/L, Principal investigator, University of Southern CaliforniaAmit Mathur, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230199
- Sponsor's protocol ID
- R01HD105557
- Acronym
- SOOTHE
- Status last verified
- Jun 2026
- First submitted
- 27 Jan 2022
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multisensory Interventions to Improve Neurodevelopmental Outcomes of Preterm Infants Hospitalized in the Neonatal Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05230199
- Acronym / sponsor ID
- SOOTHE / R01HD105557
- Conditions
- Preterm, Parent-Child Relations, Parents, Development, Infant, Sensory Integration Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 215 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- St. Louis University, Washington University School of Medicine, University of North Carolina, Harvard University, Hugo W. Moser Research Institute at Kennedy Krieger, Inc., St. Louis Children's Hospital
- Study start
- 29 May 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monitored standard of care | Active comparator | Behavioral: Monitored standard of careAt 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. |
| SENSE multisensory program | Experimental | Behavioral: SENSE multisensory programThe 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. |
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ≤ 32 weeks estimated gestational age (EGA)
- recruited within the first week of life
Key exclusion criteria (5 listed)
- > 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SENSE multisensory programIn 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. | Behavioural | SENSE multisensory program |
| Monitored standard of careInfants who receive sensory exposures only as standard of care but do not recieve the SENSE program | Behavioural | Monitored standard of care |
Primary outcome
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
11 secondary outcomes
Bayley Scales of Infant Toddler Development, 4th Edition
Time frame: 6 months and 1 year adjusted age (when completed in newborn follow-up clinic)
NICU Network Neurobehavioral Assessment Scale
Time frame: Between 35-41 weeks PMA
Sensory Profile 2
Time frame: 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
Ages and Stages Questionnaire-3
Time frame: 6 months adjusted age, 1 and 2 years adjusted age
Child Behavior Checklist (CBCL)
Time frame: 2 years adjusted
Emotional Availability Scales
Time frame: Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 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
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
Edinburgh Postnatal Depression Scale (EPDS)
Time frame: Prior to the infant's discharge from the NICU (35-41 weeks PMA)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roberta Pineda, PhD OTR/L principal investigator
University of Southern California
Amit Mathur, MD principal investigator
St. Louis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SENSE multisensory program in people with Preterm and Parent-Child Relations, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberta Pineda, PhD OTR/L ((323) 442-2850, bobbi.pineda@chan.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bayley Scales of Infant Toddler Development, 4th Edition (time frame: 2 years adjusted age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.