Multisensory Intervention for Premature Birth

(SOOTHE Trial)

Recruiting at 1 trial location

Overseen By Roberta Pineda, PhD OTR/L

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Congenital anomaly, High threat of death, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

215 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called SENSE, a multisensory intervention designed to improve the health and well-being of premature babies and their parents in the NICU (Neonatal Intensive Care Unit). The program includes activities such as massage, listening to sounds, rocking, and skin-to-skin contact, all tailored to the baby's development and health. The researchers aim to determine if these activities can boost brain activity, improve parent-child interactions, and support better development up to age 2, particularly in language skills. Babies born at or before 32 weeks and enrolled in the first week of life may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative care strategies that could enhance early development in premature infants.

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 prior data suggests that the SENSE multisensory program is safe for preterm infants?

Research has shown that the SENSE multisensory program is generally safe for premature babies. In a study with 70 preterm infants, participants in sensory activities like the SENSE program experienced no major negative effects. The program includes gentle activities such as massage, listening to calming sounds, and skin-to-skin contact, all aimed at safely supporting a baby's development.

The SENSE program provides babies with positive sensory experiences daily, and its safety is supported by research. Parents learn to perform these activities safely and effectively for their babies. The program is tailored to each baby's needs and health condition, which helps reduce any possible risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SENSE multisensory program because it offers a structured and evidence-based approach to enhancing sensory exposure for preterm infants, unlike the typical standard of care that varies widely and lacks set guidelines. This program provides specific tactile, auditory, visual, vestibular, and olfactory interventions tailored to each infant's needs, ensuring a consistent and comprehensive sensory experience throughout their NICU stay. By involving parents actively and offering a sensory support team when needed, the SENSE program aims to improve developmental outcomes by systematically incorporating essential sensory inputs during a critical period of infant growth.

What evidence suggests that the SENSE multisensory program is effective for preterm infants?

This trial compares the SENSE multisensory program with monitored standard care for preterm infants. Research has shown that multiple types of sensory activities can benefit preterm infants. The SENSE program, one of the treatments in this trial, includes gentle massage, listening to sounds, and skin-to-skin contact. Studies have found that these positive sensory experiences aid in the development of babies, especially those in the NICU. Early results suggest that structured sensory activities can improve brain function, parent-child bonding, and even language skills later on. By involving parents, the SENSE program aims to create a stable and caring environment for premature babies. ^{1 2 3 4 6}

Who Is on the Research Team?

Roberta Pineda, PhD OTR/L

Principal Investigator

University of Southern California

Amit Mathur, MD

Principal Investigator

St. Louis University

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Monitored standard of care
• SENSE multisensory program

Trial Overview

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.

How Is the Trial Designed?

Group I: SENSE multisensory program Experimental Treatment 1 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 care Active Control 1 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.

SENSE multisensory program is already approved in United States for the following indications:

Approved in United States as SENSE Program for:

• Improvement of neurodevelopmental outcomes in preterm infants
• Enhancement of parent-child interaction
• Support for parent mental health

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NICU sensory experiences associated with positive outcomes: an integrative review of evidence from 2015-2020. Pineda, R., Kellner, P., Guth, R., et al.[2023]

The SENSE program was developed to provide consistent and evidence-based positive sensory experiences for preterm infants in the NICU, utilizing strategies like music and skin-to-skin contact.

Implementation materials for the SENSE program include tailored sensory exposure guidelines and parent education, but further research is needed to evaluate its effectiveness on outcomes for both parents and infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting and enhancing NICU sensory experiences (SENSE): Defining developmentally-appropriate sensory exposures for high-risk infants. Pineda, R., Raney, M., Smith, J.[2019]

The SENSE program, designed for preterm infants in the NICU, emphasizes consistent and evidence-based sensory experiences to improve outcomes for both infants and parents, with updates informed by a comprehensive review of 57 articles and stakeholder feedback.

The 2nd edition of the SENSE program includes refinements such as more inclusive language and specific recommendations for sensory exposure, ensuring it remains relevant and effective in real-world hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting and Enhancing NICU Sensory Experiences (SENSE), 2nd Edition: An Update on Developmentally Appropriate Interventions for Preterm Infants. Pineda, R., Kellner, P., Ibrahim, C., et al.[2023]

A multisensory intervention program guided by parents for preterm infants in the neonatal intensive care unit led to significantly better outcomes in receptive language and fine-motor skills at 2 to 3 years of age, as assessed by the Bayley Scale.

The intervention particularly benefited boys in terms of language skills, while parental stress levels remained unchanged, suggesting that the program can enhance child development without increasing parental stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of a multisensory intervention for preterm infants provided by parents, on developmental abilities and on parental stress levels. Gabis, LV., Hacham-Pilosof, K., Yosef, OB., et al.[2015]

Uni-sensory interventions in NICUs, such as proprioceptive and gustatory stimuli, can help reduce apneas in preterm infants, supporting their vegetative states.

Multi-sensory interventions have longer-term benefits, including improved feeding transitions, weight gain, and better sleep-wake cycles, with parental involvement being crucial for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neonatal Care Unit Interventions on Preterm Development. Séassau, A., Munos, P., Gire, C., et al.[2023]

Premature infants showed positive responses to multiple sensory stimulation interventions, with benefits observed both immediately and lasting up to 2 years.

To enhance nursing research on sensory stimulation for premature infants, it is important to establish a theoretical framework, provide detailed descriptions of infant samples and environments, and tailor stimulation methods to preserve the infants' epigenetic integrity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary research of multimodal stimulation of premature infants: an integrated review of the literature. Mueller, CR.[2005]

Citations

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Studies investigating sensory-based interventions in the NICU with preterm infants born ≤32 weeks were identified.

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The Supporting and Enhancing NICU Sensory Experiences (SENSE) program was developed to promote consistent, age-appropriate, responsive, and evidence-based ...

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Description and evidence on the supporting ...

The SENSE program combines structured, evidence-based, multisensory interventions with parent engagement in order to optimise outcomes in the complex NICU ...