~118 spots leftby Aug 2027

Multisensory Intervention for Premature Birth

(SOOTHE Trial)

AM
RP
Overseen byRoberta Pineda, PhD OTR/L
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Southern California
Disqualifiers: Congenital anomaly, High threat of death, others
No Placebo Group
Approved in 1 Jurisdiction

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

AM

Amit Mathur, MD

Principal Investigator

St. Louis University

RP

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

My baby is less than one week old.
I am less than or equal to 32 weeks pregnant.

Exclusion Criteria

Have a suspected or confirmed congenital anomaly
> 32 weeks EGA at birth
Become wards of the state
See 2 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

NICU Stay

Infants receive either the SENSE multisensory program or standard care during their NICU hospitalization

Up to 41 weeks PMA
Daily interventions by parents or sensory support team

Follow-up

Participants are monitored for developmental outcomes and parent-child interactions at various intervals

2 years adjusted age
Assessments at 6 months, 1 year, and 2 years adjusted age

Treatment Details

Interventions

  • Monitored standard of care (Behavioural Intervention)
  • SENSE multisensory program (Behavioural Intervention)
Trial OverviewThe 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials
956
Recruited
1,609,000+

St. Louis University

Collaborator

Trials
197
Recruited
41,400+

Washington University School of Medicine

Collaborator

Trials
2,027
Recruited
2,353,000+

University of North Carolina

Collaborator

Trials
174
Recruited
1,457,000+

Harvard University

Collaborator

Trials
237
Recruited
588,000+

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Collaborator

Trials
93
Recruited
25,200+

St. Louis Children's Hospital

Collaborator

Trials
30
Recruited
83,200+

Findings from Research

The multisensory program (SENSE) applied to infants in the NICU showed a trend towards increased lethargy, indicating a potential impact on neurobehavioral outcomes, although this requires further investigation.
Infants in the SENSE program had higher Communication scores at 1-year corrected age, suggesting potential benefits for developmental outcomes, but these results were not statistically significant after adjusting for other risk factors.
Randomized clinical trial investigating the effect of consistent, developmentally-appropriate, and evidence-based multisensory exposures in the NICU.Pineda, R., Smith, J., Roussin, J., et al.[2022]
The SENSE program, aimed at enhancing sensory experiences for preterm infants, showed high feasibility with an 87.5% recruitment rate and 100% retention among the eight infants studied, indicating strong interest and commitment from families.
Post-assessment results indicated that the program effectively reduced parent stress and supported normal neurodevelopment in infants, suggesting that SENSE could be beneficial for both infants and their parents in the NICU setting.
Feasibility of Implementing a Modified SENSE Program to Increase Positive Sensory Experiences for Preterm Infants in the Neonatal Intensive Care Unit (NICU): A Pilot Study.de Castro, KN., Benson, JD., Thomas, H., et al.[2022]
A review of 57 studies on sensory-based interventions for preterm infants in the NICU revealed that most interventions were already part of the existing SENSE program, indicating a solid foundation of evidence for these practices.
New findings prompted updates to the SENSE program, including the introduction of position changes based on postmenstrual age and the initiation of visual tracking activities starting at 34 weeks PMA, enhancing developmental support for these infants.
NICU sensory experiences associated with positive outcomes: an integrative review of evidence from 2015-2020.Pineda, R., Kellner, P., Guth, R., et al.[2023]

References

Randomized clinical trial investigating the effect of consistent, developmentally-appropriate, and evidence-based multisensory exposures in the NICU. [2022]
Feasibility of Implementing a Modified SENSE Program to Increase Positive Sensory Experiences for Preterm Infants in the Neonatal Intensive Care Unit (NICU): A Pilot Study. [2022]
NICU sensory experiences associated with positive outcomes: an integrative review of evidence from 2015-2020. [2023]
Supporting and enhancing NICU sensory experiences (SENSE): Defining developmentally-appropriate sensory exposures for high-risk infants. [2019]
Multidisciplinary research of multimodal stimulation of premature infants: an integrated review of the literature. [2005]
Supporting and Enhancing NICU Sensory Experiences (SENSE), 2nd Edition: An Update on Developmentally Appropriate Interventions for Preterm Infants. [2023]
Neonatal Care Unit Interventions on Preterm Development. [2023]
The influence of a multisensory intervention for preterm infants provided by parents, on developmental abilities and on parental stress levels. [2015]